Duns Number:109903521
Device Description: 1.6MM TROCAR TIP WIRE 2X ENDED 150MM
Catalog Number
71101508
Brand Name
VLP FOOT
Version/Model Number
71101508
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120871,K120871
Product Code
JDW
Product Code Name
PIN, FIXATION, THREADED
Public Device Record Key
4b6875a3-4e0b-4ed3-8585-f8072ac925a3
Public Version Date
June 28, 2021
Public Version Number
4
DI Record Publish Date
August 29, 2015
Package DI Number
23596010626725
Quantity per Package
6
Contains DI Package
03596010626721
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |