Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Intubation teeth protector FDA UDI
- Device Name
- Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Package of 10 Individually Bagged Units FDA UDI
- Model / Reference
- E-126-010 FDA UDI
- Description
- Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Package of 10 Individually Bagged Units FDA UDI
Identifiers
- Catalog Number
- E-126-010 FDA UDI
- Primary DI / UDI-DI
- B005E1260103 FDA UDI
- FDA Product Code
- BRW FDA UDI
- GMDN Term
- Intubation teeth protector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5820 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
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
No
FDA UDI
MR Safe FDA UDI
Category: Intubation teeth protector
AincA® by Anesthesia Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intubation teeth protector.
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- EndoraGard — KERR CORPORATION · Class I
- AincA® — Anesthesia Associates, Inc. · 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
- Anesthesia Associates, Inc.
Sources (1)
- FDA UDI 1703ed2b-26d4-445a-848e-3364457597d9 35 fields · synced May 30, 2026