TITAN IMPLANTS, INC. - 4.0mm Diameter Implant 11.0mm Length SB - TITAN IMPLANT INC

Duns Number:115545837

Device Description: 4.0mm Diameter Implant 11.0mm Length SB

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More Product Details

Catalog Number

-

Brand Name

TITAN IMPLANTS, INC.

Version/Model Number

BC-4S11S

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

K042971

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

c3330790-973c-4b80-a323-12d341e71a88

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TITAN IMPLANT INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 374
2 A medical device with a moderate to high risk that requires special controls. 1073