Identity
- Trade Name
- PRIMO/ASP MEDICAL FDA UDI
- Generic Name
- Floor covering FDA UDI
- Device Name
- O.R. Absorbent Floor Drape 16" x 18" FDA UDI
- Model / Reference
- PS1618 FDA UDI
- Description
- O.R. Absorbent Floor Drape 16" x 18" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216114074 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Floor covering FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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: Floor covering
Primo/Asp Medical by Asp Global, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PRIMO/ASP MEDICAL — Asp Global, LLC · Class II
- PRIMO/ASP MEDICAL — Asp Global, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI c84c1331-3bdb-4902-8f38-634b561cadfc 33 fields · synced Jun 7, 2026