Duns Number:118087931
Device Description: Cervical Tray For Bits, SS
Catalog Number
TY20004
Brand Name
DePuy Synthes
Version/Model Number
Cervical Tray For Bits
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
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
a8ffaf76-8657-416a-9d04-cc53fd47a70d
Public Version Date
July 08, 2021
Public Version Number
5
DI Record Publish Date
November 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 133 |