Duns Number:054875224
Device Description: Titanium Scan Body for Zimmer TSV 3.5mm
Catalog Number
8000141
Brand Name
Zimmer
Version/Model Number
8000141
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
3fcdb9cc-0a33-4c5d-8a8a-78bc073cfd18
Public Version Date
October 19, 2022
Public Version Number
2
DI Record Publish Date
September 13, 2022
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 | 958 |
2 | A medical device with a moderate to high risk that requires special controls. | 1846 |