Duns Number:333623937
Device Description: COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure
Catalog Number
5147215
Brand Name
COPAL® exchange G
Version/Model Number
hip S medium
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KWL
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Public Device Record Key
b19545a9-bc63-463f-94a6-9ed487fe2b30
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 15, 2022
Package DI Number
04260102139190
Quantity per Package
144
Contains DI Package
04260102139176
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |