Identity
- Trade Name
- A.M.I. TissueBag FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- Bag for retrieving specimen. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery. FDA UDI
- Model / Reference
- TBI 100 FDA UDI
- Description
- Bag for retrieving specimen. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery. FDA UDI
Identifiers
- Catalog Number
- TBI 100 FDA UDI
- Primary DI / UDI-DI
- EAMITBI1000 FDA UDI
- 510(k) Number
- K092821 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 485 Millimeter FDA UDI
A.M.I. TissueBag by AMI Agency for Medical Innovations GmbH — 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
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI 2d47a806-cf5c-452d-a8bb-68265eb19dc2 37 fields · synced May 31, 2026