Duns Number:368715301
Device Description: Applicator with K-wire Ø1.6 mm, disposable, for 1.5 mm pins
Catalog Number
B-DIP-1500
Brand Name
Disposable Pin Applicator
Version/Model Number
B-DIP-1500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K080879
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
04723c41-96c0-4308-aff7-5d090b68fd23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 22, 2016
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 | 142 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |