Duns Number:040729840
Device Description: JOSEPH SKIN HOOK BLUNT BALL TIPS BLUE ELECTRO COATED
Catalog Number
199-421
Brand Name
JOSEPH SKIN HOOK
Version/Model Number
199-421
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)
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
4311da85-2442-4333-86d8-a308e06b533b
Public Version Date
September 22, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2018
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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |