Duns Number:190572854
Device Description: Calibrated Passing Pin Drill Tip 2.4mm X 38.1cm, 20-80mm (Plus or Minus 5 Percent)
Catalog Number
254729
Brand Name
NA
Version/Model Number
254729
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
36c32645-438c-42ec-aa1b-345e2a87d62c
Public Version Date
September 20, 2021
Public Version Number
3
DI Record Publish Date
September 01, 2015
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 | 560 |
2 | A medical device with a moderate to high risk that requires special controls. | 479 |