Duns Number:023055619
Device Description: Bulldog Clamp, 25mm Straight Open Jaws, 2"/2.5CM
Catalog Number
3795-50-01
Brand Name
SCANLAN® Reliance Bulldog Clamp
Version/Model Number
3795-50-01
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
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
0b4d3f5b-4d9f-458c-b472-5b65d103389d
Public Version Date
November 22, 2019
Public Version Number
1
DI Record Publish Date
November 14, 2019
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 | 1949 |
2 | A medical device with a moderate to high risk that requires special controls. | 855 |