Duns Number:791238046
Device Description: PICC Catheter Trimming Device
Catalog Number
-
Brand Name
NA
Version/Model Number
TRIMMER
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"
Yes
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
FZT
Product Code Name
Cutter, Surgical
Public Device Record Key
6ae4e23c-2231-4bfc-97f2-8aef9b391fbc
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10858778006529
Quantity per Package
10
Contains DI Package
00858778006522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 133 |