Identity
- Trade Name
- Burkhart Tray Sleeve Size F 11-1/2 x 10-1/2 (500) FDA UDI
- Generic Name
- Dental bib FDA UDI
- Model / Reference
- 72720837 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815878020971 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
Yes
FDA UDI
Category: Dental bib
Burkhart Tray Sleeve Size F 11-1/2 x 10-1/2 (500) by Burkhart Dental Supply Co., The — 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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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
- Burkhart Dental Supply Co., The
Sources (1)
- FDA UDI 2f994409-6c36-4c44-96a6-51b4c0b1d3b9 33 fields · synced May 30, 2026