Duns Number:054875224
Device Description: Zimmer TSV 3.5mm Open-Tray Transfer 3.5 x 10mm;. Kit contains . 1 Zimmer TSV 3.5mm Open-Tr Zimmer TSV 3.5mm Open-Tray Transfer 3.5 x 10mm;. Kit contains . 1 Zimmer TSV 3.5mm Open-Tray Transfer 3.5x10mm (00842092100295) . 1 Zimmer Screw Vent 3.5/4.5/5.7mm Guide Pin 20mm (00842092100486)
Catalog Number
8000101
Brand Name
Zimmer
Version/Model Number
8000101
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)
-
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
4584932d-7a87-4c7c-a4e5-d401d690fb42
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 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 |