Duns Number:618749857
Catalog Number
-
Brand Name
Holding and Bending Pins 2.5 – 2.8mm
Version/Model Number
20663
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
-
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
HXP
Product Code Name
Instrument, Bending Or Contouring
Public Device Record Key
cfd9f96d-29b5-4202-8ae0-18fe3b0530d7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 13, 2017
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 | 494 |
2 | A medical device with a moderate to high risk that requires special controls. | 2447 |