Catalog Number

44-000052XL

Brand Name

Extra Long UCLA .050"/1.25mm Hex Screw Branemark RP 4.1 Compatible

Version/Model Number

44-000052XL

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"

-

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

K904236,K904236

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

f0f7b1b7-cf1f-47b2-bf49-b712417cca91

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-