Duns Number:536935331
Device Description: The 16mm phalangeal yellow colored reamer is used to ream the articular surface of the pha The 16mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface.It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.
Catalog Number
-
Brand Name
Hallu®- LOCK
Version/Model Number
129726ND
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
HTO
Product Code Name
REAMER
Public Device Record Key
4ea262f9-d435-46f3-861d-b525b721d56a
Public Version Date
July 23, 2020
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 |