Duns Number:303655286
Device Description: Bag for retrieving specimen for 10mm trocars.The various types of retrieval bags belonging Bag for retrieving specimen for 10mm trocars.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
TBI1021
Brand Name
A.M.I. TissueBag Large
Version/Model Number
TBI1021
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
ad64e998-77f6-4d64-ba33-8c1e5a83a44b
Public Version Date
October 04, 2022
Public Version Number
3
DI Record Publish Date
November 28, 2018
Package DI Number
EAMITBI10211
Quantity per Package
10
Contains DI Package
EAMITBI10210
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 |