Identity
- Trade Name
- AIOBIO FDA UDI
- Generic Name
- Mouth gag, adjustable, reusable FDA UDI
- Model / Reference
- W-Block FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800043200199 FDA UDI
- FDA Product Code
- KBN FDA UDI
- GMDN Term
- Mouth gag, adjustable, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mouth gag, adjustable, reusable
Aiobio by AIOBIO Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mouth gag, adjustable, reusable.
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- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Reicodent — devemed GmbH · Class I
- Ambler Surgical — Ambler Surgical, 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
- AIOBIO Co., Ltd.
Sources (1)
- FDA UDI 47655997-9863-4c5a-8ef3-60b56d227693 32 fields · synced May 31, 2026