Duns Number:832637081
Device Description: 28MM COCR RADIAL HEAD 4MM HT EXTENSION/18.0MM-STER
Catalog Number
09402428S
Brand Name
NA
Version/Model Number
09.402.428S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2020
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112030
Product Code
KWI
Product Code Name
PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Public Device Record Key
db90c8ca-f0c5-4a56-a499-49b8420163fc
Public Version Date
July 08, 2020
Public Version Number
5
DI Record Publish Date
September 14, 2015
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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |