Branemark WP 5.1 UCLA Hex Cylinder - IMPLANT DIRECT SYBRON MANUFACTURING LLC

Duns Number:868856969

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More Product Details

Catalog Number

44-500202-WP

Brand Name

Branemark WP 5.1 UCLA Hex Cylinder

Version/Model Number

44-500202-WP

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

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

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

b8bd412d-1c5e-45ee-b8da-c8c707e8832d

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANT DIRECT SYBRON MANUFACTURING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1817
U Unclassified 6