2028855

GUDID 10705034004136

SPINAL INSTRUMENT DISC SHAVER 5mm

DEPUY SPINE, LLC

Orthopaedic implantable-device cutter
Primary Device ID10705034004136
NIH Device Record Key64511e0c-2740-4cae-9961-5864a96e02a5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2028855
Catalog Number2028855
Company DUNS107105876
Company NameDEPUY SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034004136 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


[10705034004136]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2026-03-24
Device Publish Date2016-12-31

Devices Manufactured by DEPUY SPINE, LLC

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10705034192178 - MOSS2026-03-25 MOSS MIAMI SPINE SYSTEM ROD APPROXIMATOR
10705034205090 - KEYSTONE2026-03-25 KEYSTONE GRAFT DELIVERY INSTRUMENTS CPK GRABBER TIP CASSETTE 10/12/14mm
10705034312286 - NA2026-03-25 MODIFIED INSTRUMENT DILATOR 10-12mm
10705034312309 - NA2026-03-25 MODIFIED INSTRUMENT SHAVER 7mm
10705034316581 - NA2026-03-25 MODIFIED INSTRUMENT ANATOMIC SHAVER 15mm
10705034321400 - NA2026-03-25 MODIFIED INSTRUMENT SHAVER 12mm

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