Duns Number:536935331
Device Description: The SURFIX® plate bender is used to bend the SURFIX® osteosynthesis plates to fit the bone The SURFIX® plate bender is used to bend the SURFIX® osteosynthesis plates to fit the bone configuration without damaging the threaded lipped sockets.
Catalog Number
-
Brand Name
SURFIX®
Version/Model Number
MA003ND
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
7f4b47b2-1e37-49e9-a8bb-ab8b8fc540ad
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 |