Duns Number:348489386
Device Description: ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is designed to fold around the end of a K wire and to safely protect the wearer from the risk of injury or re-injury through catching the sharp end of the K wire on clothing, bedclothes, people or other objects.Each Chiroklip box contain 25 Chiroklip pairs
Catalog Number
CKB2
Brand Name
Chiroklip wire protector 2 pack blister
Version/Model Number
CKB2
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXQ
Product Code Name
Crimper, Pin
Public Device Record Key
3116cac3-eccb-452a-bbda-ce2007ddd010
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |