Duns Number:793384496
Device Description: 7.5MM CANNULATED SCREW CASE BASE
Catalog Number
00-1147-077-01
Brand Name
Zimmer Cannulated Screw System
Version/Model Number
00-1147-077-01
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
Yes
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
5c12ec0a-216b-4f51-9f71-6652390b2aea
Public Version Date
October 14, 2021
Public Version Number
3
DI Record Publish Date
September 25, 2020
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 | 3116 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |