Duns Number:239403863
Device Description: The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue sp The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.
Catalog Number
PS3401
Brand Name
Tissue Retrieval pouch large
Version/Model Number
PS3401
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
KGY
Product Code Name
Bag, Intestine
Public Device Record Key
9145cdec-0981-4efe-92fa-2660a99e0ba4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
55051223000650
Quantity per Package
50
Contains DI Package
35051223000656
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |