Stainless Steel - Uniplanar Screw, SS, 5.50mm x 65mm - INTEGRA LIFESCIENCES CORPORATION

Duns Number:963856096

Device Description: Uniplanar Screw, SS, 5.50mm x 65mm

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More Product Details

Catalog Number

25-14-5565

Brand Name

Stainless Steel

Version/Model Number

25-14-5565

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2015

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

-

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

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

7486b601-4b48-4a1a-aa32-fee30ab57ec5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1079
2 A medical device with a moderate to high risk that requires special controls. 2066