TITAN IMPLANTS, INC. - SD Ext Hex Plastic Sleeve Non-Hex - TITAN IMPLANT INC

Duns Number:115545837

Device Description: SD Ext Hex Plastic Sleeve Non-Hex

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More Product Details

Catalog Number

-

Brand Name

TITAN IMPLANTS, INC.

Version/Model Number

LC-33PSNH

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

a7adc1a0-703f-4961-8f44-72027d587c3c

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

November 28, 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