Duns Number:536935331
Device Description: The right plate bender is used to bend the Hallu® Lock C plate in combination with the lef The right plate bender is used to bend the Hallu® Lock C plate in combination with the left plate bender in order to match the degree of dorsal flexion required by the case or by the activity of the patient.
Catalog Number
-
Brand Name
Hallu®- LOCK
Version/Model Number
299080ND
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
HXW
Product Code Name
BENDER
Public Device Record Key
8f5d4375-25f7-4e3a-b980-a302ec86f26a
Public Version Date
March 29, 2018
Public Version Number
2
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 |