Duns Number:791619393
Device Description: PHANTOM ML LIGHT CABLE, W/TEDAN CONNECTOR, SINGLE USE (5/BOX)
Catalog Number
-
Brand Name
Zimmer
Version/Model Number
ZS-0046
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2020
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
FDG
Product Code Name
Retractor, Fiberoptic
Public Device Record Key
aa6f164c-f342-4838-b0c5-4a3361126d4e
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
December 22, 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 | 2398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |