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SEPRA PACK
 Request for Information Form |
 Contact Information
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| Company Name | GENZYME CORPORATION |
| Address | 51 NEW YORK AVE. 1 MOUNTAIN RD
74-80 NEW YORK AVENUE |
| City, State, Zip | FRAMINGHAM, MA 01701 |
| Country | US |
| FDA Owner/Operator Phone | 617-252-7500 |
| FDA Medical Specialty Code | EN - Ear, Nose, Throat |
| FDA Product Code | LYA |
| FDA Classification Name | SPLINT, INTRANASAL SEPTAL |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 874.4780 |
| FDA Common Generic Name | NASAL DRESSING AND SINUS STENT |
| FDA Proprietary Device Name | SEPRA PACK |
| FDA Owner / Operator Number | 9002116 |
| FDA Owner / Operator Name | GENZYME CORPORATION |
| FDA Establishment Registration Number | 1220423 |
| FDA Registered Establishment Name | GENZYME CORPORATION |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 03-10-00 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of GENZYME CORPORATION
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | ADEPT MEDICAL LTD 2 MCDONALD STREET, MORNINGSIDE AUCKLAND, 1003 NZ 064-981-52997 / 064-981-52997 |
NEOZOLINE SEPTAL SPLINTS | INTRANASAL SEPTAL SPLINTS |
| 2 | ARTHROCARE UK LTD 128 STATION ROAD GLENFIELD, LE3 8BR UK 408-736-0224 / 408-735-6229 |
RAPID RHINO NASAL DRESSING (MULTIPLE SIZES) | NASAL SPLINT |
| 3 | ATOS MEDICAL AB KRAFTGATAN 8 HORBY, SE-24222 SW 46-415-198 00 / 46-415-198 00 |
MULTIPLE | VARIOUS |
| 4 | BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. WESTBOROUGH, MA 01581 US 508-898-9300 / 508-898-9300 |
DOYLE COMBO SPLINT | INTRANASAL SPLINT/PACKING |
| 5 | CARBYLAN BIOSURGERY, INC. 3181 PORTER DRIVE PALO ALTO, CA 94304 US 650-855-6777 / 650-855-6775 |
ADVACOAT SINUS GEL | SINUS PACKING GEL |
| 6 | EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F FOSTER CITY, CA 94404 US 650-287-2884 / 650-525-9750 |
JUVA INTRANASAL SPLINT | INTRANASAL SPLINT |
| 7 | FZIOMED, INC. 231 BONETTI DR SAN LUIS OBISPO, CA 93401 US 805-546-0610 / 805-549-7180 |
FZIOMED NASAL DRESSING & SINUS STENT | ABSORBENT INTRANASAL SPLINT |
| 8 | GENZYME CORPORATION 1125 PLEASANTVIEW TERRACE RIDGEFIELD, NJ 07657 US 617-252-7500 / 617-252-7500 |
SEPRAGEL SINUS | INTRANASAL SPLINT |
| 9 | GYRUS ENT L.L.C., SUB. OF GYRUS ACMI, INC. 2925 APPLING RD. BARTLETT, TN 38133 US 011-44-189219750 / 508-804-2739 |
MULTIPLE | VARIOUS |
| 10 | JEDMED INSTRUMENT CO. 5416 JEDMED CT. ST. LOUIS, MO 63129 US 314-845-3770 / 314-845-3770 220 |
SEPTAL SPLINT | INTRANASAL SEPTAL SPLINT |
| 11 | KETTENBACH GMBH & CO KG IM HEERFELD 7 ESCHENBURG, 35713 GM 49-277-47050 / 49-277-470558 |
SUGI RHINO ABSORBENT SHEETS, STERILE | VARIOUS TYPES OF STERILE INTRANASAL SPLINTS AND SWABS |
| 12 | MEDTRONIC XOMED, INC. 950 FLANDERS RD. MYSTIC, CT 06355 US 763-514-4000 / 904-279-7532 |
NASAL SPLINT | NASAL SPLINT |
| 13 | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216 US 763-514-4000 / 904-279-7532 |
NASAL SPLINT | NASAL SPLINT |
| 14 | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 EAGAN, MN 55121 US 651-452-1977 / 651-452-1977 |
MICROMEDICS NASAL SPLINTS | VARIOUS |
| 15 | MUELLER SPORTS MEDICINE, INC. ONE QUENCH DR. PRAIRIE DU SAC, WI 53578 US 608-643-8530 / 608-643-8530 |
MULTIPLE | VARIOUS TYPES OF NON-STERILE COTTON PLUGS |
| 16 | POLLAK (INTL.), LTD. 20, HAMLACHA NEW IND. ZONE, AFEK. ROSH HA'AYIN, 48091 IS 972-390-22885 / 972-390-22885 |
SPLINT, INTRANASAL SEPTAL | SPLINT, INTRANASAL SEPTAL |
| 17 | POLYGANICS BV L.J. ZIELSTRAWEG 1 GRONINGEN, 9713-GX NL 315-058-86588 / 315-058-86586 |
NASOPORE | NASAL DRESSING |
| 18 | SIENTRA, INC 11220 GRADER STREET,SUITE 100 DALLAS, TX 75238 US 805-562-3581 / 805-562-3581 |
SILIMED NASAL RETAINER | NASAL SPLINT |
| 19 | SILIMED-SILICONE E INSTRUMENTAL MEDICO-CIRURGICO E RUA FIGUEIREDO ROCHA,374 RIO DE JANEIRO, 21240660 BR 011-55-2136877000 / 410-451-0639 |
SILIMED NASAL RETAINER | NASAL SPLINT |
| 20 | TELEFLEX MEDICAL 375 FORBES BLVD. MANSFIELD, MA 02048 US 919-544-8000 / 919-433-4829 |
SEPRAPACK | NASAL DRESSING AND SINUS STENT |
| 21 | ULTRACELL MEDICAL TECHNOLOGIES OF CONNECTICUT, INC 183 PROVIDENCE-NEW LONDON TNPK NORTH STONINGTON, CT 06359 US 616-698-7100 / 860-599-4883 12 |
MULTIPLE | STERILE NASAL SPLINT |
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