Duns Number:832696038
Device Description: V. Mueller LEATHER VALVE CUTTER 2MM STERILE 1-USE
Catalog Number
CH8686-1
Brand Name
V. Mueller
Version/Model Number
CH8686-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2021
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
Yes
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
609056fc-6170-47f4-bc90-c54ba0c31186
Public Version Date
March 04, 2022
Public Version Number
2
DI Record Publish Date
August 17, 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 |