Identity
- Trade Name
- Releve FDA UDI
- Generic Name
- Finger-cot surgical drape FDA UDI
- Device Name
- Releve Protective Covers (30 pack) FDA UDI
- Model / Reference
- GY1530 FDA UDI
- Description
- Releve Protective Covers (30 pack) FDA UDI
Identifiers
- Catalog Number
- GY1530 FDA UDI
- Primary DI / UDI-DI
- 00850000610088 FDA UDI
- FDA Product Code
- KOH FDA UDI
- GMDN Term
- Finger-cot surgical drape FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Finger-cot surgical drape
Releve by Surgin Surgical Instrumentation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Finger-cot surgical drape.
- PREMIER VALUE — PHARMACY VALUE ALLIANCE, LLC · Class I
- Acu-Health — Apothecary Products, Inc. · Class I
- Flents — Apothecary Products, Inc. · Class I
- Walgreens — WALGREEN CO. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Equate — Walmart Stores · Class I
- Flents — Apothecary Products, Inc. · Class I
- Flents — Apothecary Products, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgin Surgical Instrumentation, Inc.
Sources (1)
- FDA UDI 2217cd28-6f80-4d4e-8b31-49934e12165d 34 fields · synced Jun 1, 2026