Identity
- Trade Name
- Pac-Dent FDA UDI
- Generic Name
- Dental bib FDA UDI
- Model / Reference
- 36 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815967020301 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Dental bib 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental bib
Pac-Dent by Pac-Dent International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental bib.
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- Patient Armor Barriers — AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. · Class II
- Health-Tec/DHP Patient Bibs — Dental Health Products Inc · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Safco Royal 4-ply bibs — Safco Dental Supply · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pac-Dent International, Inc.
Sources (1)
- FDA UDI 1b898110-333c-4a27-861d-3c070c7b7d40 32 fields · synced Jun 1, 2026