Duns Number:239505063
Device Description: Medium Right Hand Vein Hook (No. 2) Medium Right Hand Vein Hook (No. 2)
Catalog Number
S090
Brand Name
Single Use Surgical Professional
Version/Model Number
S090
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)
-
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
01abef3f-5aeb-4f19-9763-bf583d0164ff
Public Version Date
December 21, 2018
Public Version Number
3
DI Record Publish Date
August 19, 2016
Package DI Number
05055299100578
Quantity per Package
15
Contains DI Package
05055299101346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |