Identity
- Trade Name
- Andorate Disposable Endoscope Bite Block (55.5 Fr) FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Model / Reference
- GAR059 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970934720197 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Andorate Disposable Endoscope Bite Block (55.5 Fr) 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 e93995a0-81e7-46d5-a0d0-c64f1f0242f4 33 fields · synced May 30, 2026