MAX VPC™CANNULATED DRIVER HEX AO - Biomet Orthopedics, LLC

Duns Number:129278169

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More Product Details

Catalog Number

212001225

Brand Name

MAX VPC™CANNULATED DRIVER HEX AO

Version/Model Number

212001225

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K160058

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

c9d83a71-2ef5-4811-ad92-dea0460176b4

Public Version Date

October 05, 2018

Public Version Number

5

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET ORTHOPEDICS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11962
2 A medical device with a moderate to high risk that requires special controls. 28376
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4