T.L.I.F. - TLIF SG INSTRUMENTS DISTRACTOR - DEPUY SPINE, LLC

Duns Number:107105876

Device Description: TLIF SG INSTRUMENTS DISTRACTOR

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More Product Details

Catalog Number

202718300

Brand Name

T.L.I.F.

Version/Model Number

202718300

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

GDI

Product Code Name

DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

cece3a8b-b90f-4715-ab19-01ff09027b94

Public Version Date

April 23, 2019

Public Version Number

7

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