Duns Number:157565946
Device Description: P-SERIES COLLARLESS FEMORAL STEM TEMPLATE
Catalog Number
711-05-98
Brand Name
AcuMatch
Version/Model Number
711-05-98
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic manual surgical instrument
Public Device Record Key
4768ce3e-0009-4219-870f-005930559ffe
Public Version Date
August 05, 2022
Public Version Number
1
DI Record Publish Date
July 28, 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 | 3717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7206 |
| 3 | A medical device with high risk that requires premarket approval | 28 |