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BITEGARD
 Request for Information Form |
 Contact Information
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| Company Name | SHARN, INC. |
| Address | 4517 GEORGE RD., SUITE 200 |
| City, State, Zip | TAMPA, FL 33634 |
| Country | US |
| FDA Owner/Operator Phone | 813-889-9614 |
| FDA Medical Specialty Code | GU - Gastroenterology/Urology |
| FDA Product Code | MNK |
| FDA Classification Name | ENDOSCOPIC BITE BLOCK |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 876.1500 |
| FDA Common Generic Name | BITEGARD, TOOTH PROTECTOR |
| FDA Proprietary Device Name | BITEGARD |
| FDA Owner / Operator Number | 1035845 |
| FDA Owner / Operator Name | SHARN, INC. |
| FDA Establishment Registration Number | 1035845 |
| FDA Registered Establishment Name | SHARN, INC. |
| FDA Operation Code(s) |
RR - Repackager/Relabeller |
| FDA Listing Date | 07-21-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of SHARN, INC.
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 | BEIJING LONGMIAO MEDICAL DEVICES CO., LTD. NO.110 SHAN YUKOU VILLAGE, QIAOZI TOWN,HUAIROU DISTRICT BEIJING, 104402 CH 86-10-83533877 / 86-10-83533877 |
MULTIPLE | BITE BLOCK, OXGARD |
| 2 | CONMED ELECTROSURGERY 12055 ROJAS DR., SUITE G EL PASO, TX 79936 US 315-797-8375 / 303-269-8224 |
DISPOSABLE BITE BLOCK | BITE BLOCK |
| 3 | CONMED ENDOSCOPIC TECHNOLOGIES, INC. 129 CONCORD RD. BILLERICA, MA 01821 US 315-797-8375 / 978-964-4251 |
DISPOSABLE BITE BLOCK | BITE BLOCK |
| 4 | ELECTRO SURGICAL INSTRUMENT CO., INC. 37 CENTENNIAL ST. ROCHESTER, NY 14611 US 585-235-1430 / 585-235-1430 |
BITE BLOCKS FOR ENDOSCOPE | BITE BLOCKS FOR ENDOSCOPE |
| 5 | ENCOMPAS UNLIMITED, INC. 2219 WHITFIELD PARK DR. SARASOTA, FL 34243 US 941-751-3385 / 941-751-3385 |
ST-94, OB-10 ENDOSCOPY BITE BLOCK | ENDOSCOPY BITE BLOCK |
| 6 | ENDO-TECHNIK W. GRIESAT GMBH HEILIGENSTOCK 32 SOLINGEN, D-42697 GM 480-897-2772 202 / 480-897-2772 |
MULTIPLE BRAND NAMES | BITE BLOCK |
| 7 | HONGLONG DEVELOPMENT COMPANY OF ZHUHAI S.E.Z. 2/F., NANLI BUILDING 2372 MEIHUA XI ROAD ZHUHAI, GUANGDONG, 519075 CH 86-756-8500080 / 86-756-8500080 |
BITE BLOCK | BITE BLOCK |
| 8 | HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. BIRMINGHAM, AL 35211 US 205-314-3920 / 205-314-3920 |
MULTIPLE | BITE BLOCK |
| 9 | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. SOUTHEND-ON-SEA, ESSEX, SS25QH UK 017-026-16333 / 441-702-444276 |
ENDOSCOPE MOUTHGUARD | BITE BLOCK FOR ENDOSCOPE |
| 10 | MONTEREY INNOVATIVE PRODUCTS 5439 QUAIL WAY CARMEL, CA 93923 US 831-625-1828 / 831-625-1828 |
SUCTION BITE BLOCK | GASTROSCOPY BITE BLOCK |
| 11 | MTP MEDICAL TECHNICAL PROMOTION GMBH TAKE-OFF GEWERBE PARK 46 NEUHAUSEN OBECK, D-78579 GM 49-74-617080 / 310-348-4201 |
BITE PROTECTORS, DISPOSABLE | ACCESSORIES, BITE BLOCKS, FOR ENDOSCOPE |
| 12 | OSUNG MND CO., LTD 324, KUNHA-RI, WOLKOT-MYEON KIMPO, 415-870 KS 82-31-9875395 / 82-31-9875395 |
MULTIPLE | VARIOUS |
| 13 | RICHARD WOLF GMBH PFORZHEIMER STR. 32 KNITTLINGEN, 75438 GM 011-49-704335-0 / 847-913-1113 380 |
ACCESSORIES, BITE BLOCKS, FOR ENDOSCOPE | BITE BLOCK |
| 14 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 US 011-49-704335-0 / 847-913-1113 380 |
ACCESSORIES, BITE BLOCKS, FOR ENDOSCOPE | BITE BLOCK |
| 15 | THE SCOPE EXCHANGE, INC. 4210 TUDOR LANE GREENSBORO, NC 27410 US 336-544-2100 101 / 336-544-2100 101 |
OPTI-GUARD ENDOSCOPY BITE BLOCK | ENDOSCOPY BITE BLOCK |
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