Duns Number:597723837
Device Description: CrocClamp™ (Non-Reopening Clamp) is a device that permanently and completely occludes the CrocClamp™ (Non-Reopening Clamp) is a device that permanently and completely occludes the tubing fluid path.
Catalog Number
A100111
Brand Name
CrocClamp™ (Non-Reopening Clamp)
Version/Model Number
A100111
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KSD
Product Code Name
Device, Heat-Sealing
Public Device Record Key
02ab0659-e442-412a-bf6f-031fa94fdbe4
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 20, 2020
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |