Duns Number:040729840
Device Description: BEST INTESTINAL CLAMP
Catalog Number
10-0571
Brand Name
BEST INTESTINAL CLAMP
Version/Model Number
10-0571
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
FFR
Product Code Name
DEVICE, LOCKING, FOR INTESTINAL CLAMP
Public Device Record Key
e171bdde-c0b8-46a5-839b-a001d3258e34
Public Version Date
May 15, 2019
Public Version Number
3
DI Record Publish Date
September 11, 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 |