Duns Number:109903521
Device Description: THS GUIDE WIRE
Catalog Number
76519911
Brand Name
CHS
Version/Model Number
76519911
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 11, 2018
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
K121393
Product Code
HRY
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
621cf705-ac54-4a5a-828f-89f72f18e645
Public Version Date
October 05, 2018
Public Version Number
5
DI Record Publish Date
August 29, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |