Identity
- Trade Name
- Topmed FDA UDI
- Generic Name
- Dental bib FDA UDI
- Device Name
- It is often used as a protective pad in stomatology examination to prevent blood and water, etc., to avoid contaminating clothing or countertops causing cross infection. One side has good water absorption and the other side is leak-proof FDA UDI
- Model / Reference
- M2001 FDA UDI
- Description
- It is often used as a protective pad in stomatology examination to prevent blood and water, etc., to avoid contaminating clothing or countertops causing cross infection. One side has good water absorption and the other side is leak-proof FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975889410100 FDA UDI
- FDA Product Code
- KHR FDA UDI
- GMDN Term
- Dental bib FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bib
Topmed by Xiantao Topmed Nonwoven Protective Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
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 I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI f454f736-3906-460c-9a6d-6617eebefe27 33 fields · synced Jun 8, 2026