Identity
- Trade Name
- 3PLY SURGICAL MASK FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Model / Reference
- FM-EU2001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809783490624 FDA UDI
- FDA Product Code
- QKR FDA UDI
- GMDN Term
- Public face mask, single-use FDA UDI
Classification
- Device Class
- N 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Public face mask, single-use
3ply Surgical Mask by Unicoglobal, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Halyard — O&M HALYARD, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · 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 N | Pending data |
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Manufacturer
- Manufacturer
- Unicoglobal, Inc.
Sources (1)
- FDA UDI 496c1fdf-ee96-4f77-96a7-e84646028638 32 fields · synced Jun 8, 2026