Duns Number:025398094
Device Description: Cryogen Canister, R134a, can, ea
Catalog Number
VIVCC03
Brand Name
CRYOGEN CANISTER
Version/Model Number
VIVCC03
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
-
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
K082962,K082962
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
5a3ddc9d-8728-444a-b893-72e22e7adabc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
10850794007054
Quantity per Package
4
Contains DI Package
00850794007057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |