Duns Number:212039119
Device Description: Impervious, assymetric bag for the endoscopic retrieval of tissue. Volume 100 mL. Port siz Impervious, assymetric bag for the endoscopic retrieval of tissue. Volume 100 mL. Port size 10 mm.
Catalog Number
24005
Brand Name
nubert
Version/Model Number
24005
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K033842,K033842
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
56d46960-73c4-4e6c-9009-1093caf794cf
Public Version Date
April 20, 2022
Public Version Number
5
DI Record Publish Date
September 08, 2016
Package DI Number
05019829240059
Quantity per Package
10
Contains DI Package
05019829239947
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |