N/A - THOMAS RADIOLUCENT LEG SPLINT STRAP MEDIUM - ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Duns Number:137354267

Device Description: THOMAS RADIOLUCENT LEG SPLINT STRAP MEDIUM

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More Product Details

Catalog Number

00-1232-031-00

Brand Name

N/A

Version/Model Number

00-1232-031-00

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"

Yes

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

HST

Product Code Name

Apparatus, Traction, Non-Powered

Device Record Status

Public Device Record Key

45f485c7-96df-4e50-969c-91fa090603ab

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

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