TOTALSHIELD® - TOTALSHIELD EVALUATION KIT - ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Duns Number:137354267

Device Description: TOTALSHIELD EVALUATION KIT

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More Product Details

Catalog Number

89-9901-000-00

Brand Name

TOTALSHIELD®

Version/Model Number

89-9901-000-00

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)

Yes

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

FYA

Product Code Name

GOWN, SURGICAL

Device Record Status

Public Device Record Key

ce08d7e6-68b4-4747-b377-9d592f4a0440

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1447
2 A medical device with a moderate to high risk that requires special controls. 96