Duns Number:645681094
Device Description: VORSE (U.S. Pattern) Tube Occluding Clamp, Straight, Serrated, 7-1/2"
Catalog Number
15-268-DB
Brand Name
CROWN SURGICAL
Version/Model Number
CLAMPS
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
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
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
8eddc139-1c1b-4077-90aa-308d03def138
Public Version Date
March 09, 2021
Public Version Number
1
DI Record Publish Date
March 01, 2021
Package DI Number
B92415268DB2
Quantity per Package
264
Contains DI Package
B92415268DB0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARDBOARD BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |