Identity
- Trade Name
- Astek FDA UDI
- Generic Name
- Dental bib FDA UDI
- Device Name
- Pegasus Bib Holder - blue FDA UDI
- Model / Reference
- 18201 FDA UDI
- Description
- Pegasus Bib Holder - blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840326423646 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
Yes
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
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: Dental bib
Astek by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental bib.
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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
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI df6b1324-7338-472d-a007-28b759db7842 34 fields · synced Jun 1, 2026