Duns Number:008162518
Device Description: Bone Hook 15", 60mm blunt, plastic hdl black, w/end plate
Catalog Number
gS 45.5060
Brand Name
gSource
Version/Model Number
gS 45.5060
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIK
Product Code Name
Hook, Bone
Public Device Record Key
a18bee6f-17e2-4455-bd6d-3b39397eea66
Public Version Date
August 29, 2022
Public Version Number
3
DI Record Publish Date
January 02, 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 | 4617 |
2 | A medical device with a moderate to high risk that requires special controls. | 280 |