Duns Number:486711679
Device Description: RADIAL HEAD W/ Ø22MM HD, Ø8.5MM STM,10(+3)MM HD HT,STER
Catalog Number
09405283S
Brand Name
NA
Version/Model Number
09.405.283S
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
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
K183618,K183618
Product Code
KWI
Product Code Name
PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Public Device Record Key
15ef81c9-8c13-43ef-bb83-4834f21672f5
Public Version Date
May 02, 2022
Public Version Number
2
DI Record Publish Date
June 17, 2020
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |