Duns Number:333623937
Device Description: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stag
Catalog Number
5034792
Brand Name
COPAL® exchange G
Version/Model Number
hip S long
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K191016,K191016,K191016
Product Code
KWL
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Public Device Record Key
a2149353-0f85-481f-b317-8e251d63088e
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
Package DI Number
04260102136694
Quantity per Package
144
Contains DI Package
04260102136670
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 |