Duns Number:071595540
Device Description: 8MM PINN-ACL CROSS PIN SYSTEM, GRAFT HARNESS WITH CANNULA
Catalog Number
CPH-8000
Brand Name
PINN-ACL
Version/Model Number
CPH-8000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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
K043106
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
377cdfaf-4a69-4772-850a-e1c2fe6e10ab
Public Version Date
June 07, 2022
Public Version Number
6
DI Record Publish Date
October 24, 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |