Duns Number:157565946
Device Description: ALT HA S COMP BRCH SZ 15
Catalog Number
191-03-15
Brand Name
Alteon
Version/Model Number
191-03-15
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
K182462,K162732
Product Code
KWL
Product Code Name
Prosthesis, hip, hemi-, femoral, metal
Public Device Record Key
52b7c307-0040-4589-b0ff-83e999e4fdd5
Public Version Date
August 26, 2022
Public Version Number
1
DI Record Publish Date
August 18, 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 |