Duns Number:008162518
Device Description: K-Wire Dispenser 13", holds 9" & 12" Ø 1.4mm [.054"] unthreaded wire, plastic cap, white
Catalog Number
gS 98.2015
Brand Name
gSource
Version/Model Number
gS 98.2015
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
aa20d594-35f0-4400-84a8-8c62ccb9ad30
Public Version Date
August 31, 2022
Public Version Number
3
DI Record Publish Date
November 02, 2020
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 | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |