Duns Number:832696038
Device Description: PEMBERTON SIGMOID ANASTOMOSIS CLAMP, ANGLED JAWS WITH HEAVY LONGITUDINAL RIDGE OVERALL LEN PEMBERTON SIGMOID ANASTOMOSIS CLAMP, ANGLED JAWS WITH HEAVY LONGITUDINAL RIDGE OVERALL LENGTH 9-1/2" (24.1CM)
Catalog Number
SU7090
Brand Name
V. Mueller
Version/Model Number
SU7090
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
HXD
Product Code Name
CLAMP
Public Device Record Key
99c1f264-fede-482d-9980-1108e96e01db
Public Version Date
August 21, 2019
Public Version Number
4
DI Record Publish Date
September 18, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |