Identity
- Trade Name
- Andorate® Bite Block 66 Fr with Oxygen Connection FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Model / Reference
- GAR044 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106950560 FDA UDI
- FDA Product Code
- MNK FDA UDI
- GMDN Term
- Endoscopic bite block, basic, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Andorate® Bite Block 66 Fr with Oxygen Connection by GA Health Company Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- GA Health Company Limited
Sources (1)
- FDA UDI ad2ad098-f599-4b9c-a4a0-a40fab5276a8 33 fields · synced May 30, 2026