Duns Number:536935331
Device Description: The radel quick coupling system is used to allow the engagement of the various metatarsal The radel quick coupling system is used to allow the engagement of the various metatarsal and phalangeal reamers with 6.0mm diameter tri shank attachments, over the 1.6mm K-wires, for motor power reaming.
Catalog Number
-
Brand Name
Hallu®-FIX
Version/Model Number
129710ND
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"
Yes
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
HWE
Product Code Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Public Device Record Key
d0d0cc19-7b6f-4686-91db-ccf2b5d33a2c
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
May 26, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |