Compression Slide - Compression Slide, Ulna Osteotomy Plate - I.T.S. GmbH

Duns Number:303456917

Device Description: Compression Slide, Ulna Osteotomy Plate

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

680876

Brand Name

Compression Slide

Version/Model Number

680876

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

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

HWN

Product Code Name

Instrument, Compression

Device Record Status

Public Device Record Key

6cacfc36-b3d8-4a2d-abcf-4c20b6e19bc6

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 2018

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