611 - ANKLE FUSION NAIL - TORNIER

Duns Number:260324876

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More Product Details

Catalog Number

VJU080

Brand Name

611 - ANKLE FUSION NAIL

Version/Model Number

VJU080

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

Yes

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

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Record Status

Public Device Record Key

2f7816bb-eab2-4630-9b8b-2daa1d8fd2ee

Public Version Date

March 24, 2022

Public Version Number

4

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TORNIER" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 689
2 A medical device with a moderate to high risk that requires special controls. 1365