VSP - VSP SPINE SYSTEM T-HANDLE LOCK NUT WRENCH 7.94mm - DEPUY SPINE, LLC

Duns Number:107105876

Device Description: VSP SPINE SYSTEM T-HANDLE LOCK NUT WRENCH 7.94mm

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More Product Details

Catalog Number

202542

Brand Name

VSP

Version/Model Number

202542

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2018

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

HXC

Product Code Name

WRENCH

Device Record Status

Public Device Record Key

4798c04e-728d-4978-be7c-c5e59f16c77d

Public Version Date

July 31, 2018

Public Version Number

4

DI Record Publish Date

December 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5839
2 A medical device with a moderate to high risk that requires special controls. 2784
U Unclassified 20