Duns Number:120818216
Device Description: V-CUTTER CATHETER TRIMMING TOOL 2FR-6FR
Catalog Number
AMS-850TC
Brand Name
VYGON
Version/Model Number
AMS-850TC
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOK
Product Code Name
SCISSORS, MEDICAL, DISPOSABLE
Public Device Record Key
bcf60dc4-1fc7-4bdc-b392-ad7d9f2673dd
Public Version Date
February 12, 2021
Public Version Number
1
DI Record Publish Date
February 04, 2021
Package DI Number
50849884002107
Quantity per Package
360
Contains DI Package
30849884002103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |