Identity
- Trade Name
- Avaline Medical NJ LLC FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- Tissue/Poly Flat Stretcher Sheets/Drape Sheets, 40" x 90", Blue (25 Pack) FDA UDI
- Model / Reference
- ds4090x25 FDA UDI
- Description
- Tissue/Poly Flat Stretcher Sheets/Drape Sheets, 40" x 90", Blue (25 Pack) FDA UDI
Identifiers
- Catalog Number
- ds4090x25 FDA UDI
- Primary DI / UDI-DI
- 00850025452670 FDA UDI
- FDA Product Code
- KME FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6060 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
No
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: Patient surgical drape, single-use
Avaline Medical NJ LLC by Avaline Medical NJ Limited Liability Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Avaline Medical NJ Limited Liability Company
Sources (1)
- FDA UDI ee37c492-6d8e-40a5-923f-1cd36bbad99b 35 fields · synced Jun 8, 2026