Catalog Number

95-2720

Brand Name

"2.4MM" SYSTEM

Version/Model Number

95-2720

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2020

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"

-

For Single-Use

Yes

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

K001238,K113512

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

39c74cb8-8293-45d7-bc92-fc8334549539

Public Version Date

July 27, 2020

Public Version Number

4

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-