Identity
- Trade Name
- Andorate PearlCatch Single Chamber Polyp Trap FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- Polyp Trap FDA UDI
- Model / Reference
- GAR014 FDA UDI
- Description
- Polyp Trap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970934720159 FDA UDI
- FDA Product Code
- CBC FDA UDI
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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 PearlCatch Single Chamber Polyp Trap by GA Health Company Limited — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GA Health Company Limited
Sources (1)
- FDA UDI 09668774-84f5-48be-b886-d40b5e90ddcb 34 fields · synced Jun 8, 2026