Identity
- Trade Name
- A.M.I.-dock TissueBag DLU Large FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. 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
- A10 212 FDA UDI
- Description
- Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. 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
- A10 212 FDA UDI
- Primary DI / UDI-DI
- EAMIA102120 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 — 180 Millimeter FDA UDI
A.M.I.-dock TissueBag DLU Large 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 |
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Manufacturer
- Manufacturer
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI 00e72498-fc74-4cf5-9723-d328fa866115 37 fields · synced Jun 1, 2026