Duns Number:212039119
Device Description: Impervious bag for the endoscopic retrieval of tissue. Volume 2500 mL. Port size 15 mm.
Catalog Number
24002
Brand Name
hubert
Version/Model Number
24002
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
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
6c22ed4e-67f0-460b-a4b5-8a8e058e06ba
Public Version Date
April 20, 2022
Public Version Number
5
DI Record Publish Date
September 08, 2016
Package DI Number
05019829240028
Quantity per Package
5
Contains DI Package
05019829239978
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 |