Duns Number:239403863
Device Description: Secure Catch Tissue Retrieval Pouch has applications in laparoscopic procedures for the sa Secure Catch Tissue Retrieval Pouch has applications in laparoscopic procedures for the safe, convenient removal of tissue specimens such as the appendix, gallbladder, ovaries, fibroids, myomas, omentum, spleen and bowel.
Catalog Number
PS3404
Brand Name
Secure catch tissue retrieval pouch large
Version/Model Number
PS3404
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
3a4096d9-3459-4cd8-8d5b-61a0e6026006
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
35051223007778
Quantity per Package
25
Contains DI Package
05051223007777
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 |