DePuy Synthes - Cervical Inst 1 Tray, Stainless Steel - Tecomet

Duns Number:118087931

Device Description: Cervical Inst 1 Tray, Stainless Steel

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More Product Details

Catalog Number

TY20005

Brand Name

DePuy Synthes

Version/Model Number

Cervical Inst 1 Tray

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

618c82e7-594f-4a4f-8318-352d5203b1ed

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

November 15, 2017

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