Identity
- Trade Name
- Airway Armor® 25pk Small EUDAMEDAirway Armor® FDA UDI
- Generic Name
- Dental throat shield FDA UDI
- Device Name
- Non-Sterile Dental Isolation and Barrier Devices – Single Use EUDAMEDAirway Armor 25pk Small FDA UDI
- Model / Reference
- 50Z960SM EUDAMEDFDA UDI
- Description
- Airway Armor 25pk Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840161304794 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000335 EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Dental throat shield FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 11.7 Centimeter FDA UDIWidth — 16.5 Centimeter FDA UDI
Airway Armor® 25pk Small by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08401613000335 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED d644b019-255a-4c8e-b206-3acac50094f0 61 fields · synced Jul 20, 2026
- FDA UDI df1aa0f8-52a4-43e3-a561-b3f0e7fbb04a 34 fields · synced May 30, 2026