Duns Number:303655286
Device Description: Mag for retrieving speciment for 10 mm trocars.The various types of retrieval bags belongi Mag for retrieving speciment for 10 mm 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.fsing.
Catalog Number
TBI1011
Brand Name
A.M.I. TissueBag Premium
Version/Model Number
TBI1011
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
b5e253ac-6069-4a48-bbb3-a83b63fff14a
Public Version Date
April 12, 2019
Public Version Number
2
DI Record Publish Date
November 28, 2018
Package DI Number
EAMITBI10111
Quantity per Package
10
Contains DI Package
EAMITBI10110
Package Discontinue Date
-
Package Status
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 |