Duns Number:832696038
Device Description: FRANKFELDT RECTAL SNARE SET INCLUDES INSULATED STEM & HINGED SNARE LOOP OVERALL LENGTH 16" FRANKFELDT RECTAL SNARE SET INCLUDES INSULATED STEM & HINGED SNARE LOOP OVERALL LENGTH 16" (40.6 CM)
Catalog Number
SU660-016
Brand Name
V. Mueller
Version/Model Number
SU660-016
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2016
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
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
f56c2d86-e69d-4fb6-9244-c6f72d3f4150
Public Version Date
August 29, 2019
Public Version Number
3
DI Record Publish Date
September 24, 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 |