Duns Number:559784736
Device Description: Laboratory component for prior generation Vistafix
Catalog Number
90796
Brand Name
Guide pin 20 mm
Version/Model Number
90796
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
-
Product Code
FZE
Product Code Name
PROSTHESIS, NOSE, INTERNAL
Public Device Record Key
334f8ca9-e5e1-4d98-88e5-164a879980f1
Public Version Date
December 21, 2020
Public Version Number
5
DI Record Publish Date
June 07, 2017
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 276 |