Duns Number:832696038
Device Description: MIS SCRS - 125 DEG ANGLED BLDS 3.5MM SHFT, RND SQUEEZE HANDLE WORKING LENGTH 10" (25CM) OV MIS SCRS - 125 DEG ANGLED BLDS 3.5MM SHFT, RND SQUEEZE HANDLE WORKING LENGTH 10" (25CM) OVERALL LENGTH 13.25" (33.5CM)
Catalog Number
CH5709-1
Brand Name
V. Mueller
Version/Model Number
CH5709-1
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
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
9c338628-f4b5-4cad-a949-7d2ac08e9e28
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |