Duns Number:832696038
Device Description: DEBAKEY SATINSKY CLAMP SMALL JAWS, LENGTH 3-1/8" (7.9CM), DEPTH 1/2" (1.3CM) OVERALL LENGT DEBAKEY SATINSKY CLAMP SMALL JAWS, LENGTH 3-1/8" (7.9CM), DEPTH 1/2" (1.3CM) OVERALL LENGTH 10-3/8" (26.2CM)
Catalog Number
CH7305
Brand Name
V. Mueller
Version/Model Number
CH7305
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
fef59ec3-931f-468c-823f-db7d9c70f6c2
Public Version Date
July 13, 2020
Public Version Number
5
DI Record Publish Date
September 30, 2016
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |