Identity
- Trade Name
- MARK3 FDA UDI
- Generic Name
- Dental bib FDA UDI
- Device Name
- T Style Handle Sleeves 4" x 5-3/4" 500/bx. - MARK3 FDA UDI
- Model / Reference
- 2127 FDA UDI
- Description
- T Style Handle Sleeves 4" x 5-3/4" 500/bx. - MARK3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D79621271 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
No
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
Mark3 by Cargus 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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- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- 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
- Cargus International, Inc
Sources (1)
- FDA UDI 19d9564d-d2a3-4b5e-869c-f02f82d9c85a 33 fields · synced Jun 8, 2026