Duns Number:317409001
Catalog Number
02-029-99-1101
Brand Name
PIN DRIVER
Version/Model Number
02-029-99-1101
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFC
Product Code Name
Driver, Surgical, Pin
Public Device Record Key
a7d670ef-b4fd-4c51-afaf-95e1a3983312
Public Version Date
April 03, 2020
Public Version Number
2
DI Record Publish Date
December 21, 2018
Package DI Number
24053613279165
Quantity per Package
1
Contains DI Package
14053613279168
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
tubular bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 154 |
2 | A medical device with a moderate to high risk that requires special controls. | 70 |