Duns Number:832696038
Device Description: DEMARTEL-WOLFSON COLON CLAMP OVERALL LENGTH 4-5/8" (11.8CM) SET OF THREE (X 3)
Catalog Number
SU10081
Brand Name
V. Mueller
Version/Model Number
SU10081
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
a59a4e90-7b69-4ba3-9fcf-04a10e79c82d
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
April 15, 2020
Package DI Number
70885403275960
Quantity per Package
3
Contains DI Package
10885403129131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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 |