Duns Number:041116500
Device Description: Hand Held Liquid Nitrogen Delivery System Accessory - 3cm Ball Probes
Catalog Number
201-3
Brand Name
3cm Ball Probes
Version/Model Number
201-3
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
8d6e02e5-84f5-4eae-8d69-bf8a98788cf8
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 72 |