Tornier Simpliciti - CORE EXTRACTOR - TORNIER, INC.

Duns Number:968990812

Device Description: CORE EXTRACTOR

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More Product Details

Catalog Number

9722936

Brand Name

Tornier Simpliciti

Version/Model Number

9722936

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

HWB

Product Code Name

EXTRACTOR

Device Record Status

Public Device Record Key

50ad56b8-e52e-4f89-a2d4-06cf74d2f44f

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TORNIER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1670
2 A medical device with a moderate to high risk that requires special controls. 3042