DePuy Synthes - Cervical Bit & Lid Aluminum - Tecomet

Duns Number:118087931

Device Description: Cervical Bit & Lid Aluminum

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More Product Details

Catalog Number

854779

Brand Name

DePuy Synthes

Version/Model Number

Cervical Bit & Lid, AL

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

-

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

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

03fdbe64-a7d6-4556-9613-85cd2b2a4b59

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

May 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECOMET" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 133