Duns Number:809529469
Device Description: Cryoablation System Accessory
Catalog Number
FPRCH6105
Brand Name
Helium Supply Line (3 m), bar
Version/Model Number
FPRCH6105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 15, 2017
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
3c4a716c-ba95-4dec-bb70-547fa7d6e1ab
Public Version Date
April 08, 2022
Public Version Number
7
DI Record Publish Date
August 15, 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. | 43 |