Duns Number:876570990
Device Description: Cottle Single Hook Small Deep Curve OL 133mm (5 1/4")
Catalog Number
-
Brand Name
Skin Hook
Version/Model Number
15-192002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
GDG
Product Code Name
Hook, Surgical, General & Plastic Surgery
Public Device Record Key
f03fbe23-6cdf-4799-94c4-82cc0d27d270
Public Version Date
April 22, 2022
Public Version Number
1
DI Record Publish Date
April 14, 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 | 120 |