Duns Number:085976260
Device Description: Acet. Insert, Rimless, 10° Hood, VitalitE, 36mm ID, 54mm
Catalog Number
1725-0-3654
Brand Name
CS2 Acet. Cup Sys. - VitalitE
Version/Model Number
1725-0-3654
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OQG
Product Code Name
Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
Public Device Record Key
fe525806-28da-40a2-bde2-3b1846f2955b
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
January 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3570 |
| 3 | A medical device with high risk that requires premarket approval | 108 |