Cannulated Femur Nail, Right - Cannulated Femur Nail, Right, D=10mm, L=360mm - I.T.S. GmbH

Duns Number:303456917

Device Description: Cannulated Femur Nail, Right, D=10mm, L=360mm

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More Product Details

Catalog Number

12110-360

Brand Name

Cannulated Femur Nail, Right

Version/Model Number

12110-360

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

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

d8b3d9d8-d952-45fd-9f96-360738ebd9d9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I.T.S. GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 410
2 A medical device with a moderate to high risk that requires special controls. 1463