Duns Number:157565946
Device Description: ACETABULAR AUGMENT RASP, GROUP 2, SMALL, 8mm
Catalog Number
187-02-08
Brand Name
NA
Version/Model Number
187-02-08
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
K101761,K113609
Product Code
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
0d615447-895a-4309-8849-7f182ad9aa2a
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 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 |