NEONATAL EYE COVERS MANUFACTURED BY DEROYAL SURGICAL

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NEONATAL EYE COVERS

Request for Information Form	Contact Information
Company Name	DEROYAL SURGICAL - ROSE HILL
Address	100 ROSE HILL INDUSTRIAL PARK
City, State, Zip	ROSE HILL, VA 24281
Country	US
FDA Owner/Operator Phone	865-938-7828
FDA Medical Specialty Code	HO - General Hospital
FDA Product Code	FOK
FDA Classification Name	PAD, NEONATAL EYE
FDA Device Classification Code	General Controls
FDA Regulation Number	880.5270
FDA Common Generic Name	NEONATAL EYE COVERS
FDA Proprietary Device Name	NEONATAL EYE COVERS
FDA Owner / Operator Number	1044833
FDA Owner / Operator Name	DEROYAL INDUSTRIES, INC.
FDA Establishment Registration Number	1046367
FDA Registered Establishment Name	DEROYAL SURGICAL - ROSE HILL
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	11-16-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of DEROYAL SURGICAL - ROSE HILL

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	BILINK INTERNATIONAL, INC. 8329 LEFFERTS BLVD #1 KEW GARDENS, NY 11415 US 718-791-0732 / 718-791-0732	BILINK USA	NEONATAL EYE PAD
2	DONGGUAN POSEY MEDICAL LTD. FUMIN ROAD, TANGLI VILLAGE FENGGANG TOWN, DONGGUAN GUANGDONG, CH 626-443-3143 / 626-454-2135	POSEY NEWBORN EYE PROTECTOR	PAD, NEONATAL EYE
3	DONGJIN INDUSTRY 298-3, SAMJUN-DONG, OJUNG-KU BUCHUN CITY, KYUNGKI-DO, 421-810 KS 82- 32-6779118-9 / 82- 32-6779118-9	EYEMAX	NON-STERILE NEONATAL EYE PAD
4	GENESIS MEDICAL PRODUCTS, INC. 40 FARMHILL RD. WRENTHAM, MA 02093 US 508-876-1063 / 508-876-1063	SPECIAL-CARE EYE PROTECTORS	PHOTOTHERADY EYE PROTECTORS
5	HEALTH CARE LOGISTICS, INC. 3605 URBANCREST INDUSTRIAL DR. GROVE CITY, OH 43123 US 800-848-1633 / 800-848-1633	NEO SHADES	VARIOUS SIZES
6	J. T. POSEY CO. 5635 PECK RD. ARCADIA, CA 91006 US 626-443-3143 / 626-454-2135		POSEY NEWBORN EYE PROTECTOR
7	LUDLOW TECHNICAL PRODUCTS CANADA, LTD. 215 HERBERT ST. GANANOQUE, ONTARIO, K7G 2Y7 CA 508-261-8587 / 508-261-8587	BABY SHADE	LIGHT THERAPY PROTECTIVE EYEWEAR, SINGLE-USE
8	MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. 300 WEST SALT LAKE CITY, UT 84107 US 801-266-5300 / 801-327-9843	EYEMAX	PHOTOTHERAPY EYE SHIELD
9	NASCOR PTY. LTD. UNIT 17; 77-79, BOURKE ROAD ALEXANDRIA SYDNEY NSW, 2015 AS 612-970-08264 / 612-970-08264	BILIBAND	PHOTOTHERAPY EYE SHIELD
10	NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. SAN CARLOS, CA 94070 US 800-255-3901 / 650-801-7306	BILIBAND	PHOTOTHERAPY EYE SHIELD
11	NEOTECH PRODUCTS, INC. 27822 FREMONT CT. VALENCIA, CA 91355 US 800-966-0500 / 661-775-7466	NEOSHADES	PHOTOTHERAPY EYE SHIELDS
12	OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH SEATTLE, WA 98108 US 800-255-3901 / 800-426-0353 5137	STERILE INFANT EYE COVER FOR PHOTOTHERAPY	VARIOUS MODELS
13	PANPAC MEDICAL CORPORATION NO. 202, 6F-1.2, SEC.3 TATONG ROAD SHI-CHIH CITY, TAIPEI HSIEN, TW 886-2-86472242 / 215-946-1954	KEEN-AIRE MASK	NEONATAL MASK
14	PEDIA PALS, LLC. 965 HIGHWAY 169 N. PLYMOUTH, MN 55441 US 763-546-4161 / 763-546-4161	PAD, NEONATAL EYE	PHOTOTHERAPY EYE PATCH
15	PHARMELITE,LTD. 63 JALAN PEMIMPIN #02-07 , 2057 SN 65-635-39128 / 818-996-0600	PAD, NEONATAL EYE	PAD, NEONATAL EYE
16	POSEY, S.A. DE C.V. AVE FERROCARRIL # 16901 BODEGA 64, COL RIO TIJUANA 3RA ETAPA TIJUANA, B.C., C.P.22664 MX 626-443-3143 / 626-454-2135	POSEY NEWBORN EYE PROTECTOR	PAD, NEONATAL EYE
17	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US 724-387-4559 / 724-387-4559	WEESPECS	PHOTOTHERAPY MASK
18	SMALL BEGINNINGS, INC. 17525 ALDER ST., #28 HESPERIA, CA 92345 US 800-676-0462 / 800-676-0462	BILI BONNET	PHOTO-THERAPY MASK NEONATAL EYE PAD