Duns Number:303655286
Device Description: Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm.The various types of 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.
Catalog Number
A10 211
Brand Name
A.M.I.-dock TissueBag DLU
Version/Model Number
A10 211
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092821,K092821
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
c04976bb-76af-4a66-88e1-da9d57ae778f
Public Version Date
October 04, 2022
Public Version Number
3
DI Record Publish Date
November 28, 2018
Package DI Number
EAMIA102111
Quantity per Package
10
Contains DI Package
EAMIA102110
Package Discontinue Date
September 30, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |