698344571

GUDID 10705034569277

MODIFIED INSTRUMENT INSERTION BLADE 12-14mm

DEPUY SPINE, LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID10705034569277
NIH Device Record Key90f3018f-972e-4e29-8b82-d5bed7064fcf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number698344571
Catalog Number698344571
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
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034569277 [Primary]

FDA Product Code

HWRDRIVER, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


[10705034569277]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

Devices Manufactured by DEPUY SPINE, LLC

10705034459677 - N/A2024-03-05 MODIFIED INSTRUMENT PENFIELD, UP ANGLE, #4
10705034575889 - N/A2024-02-12 MODIFIED INSTRUMENT DRILL GUIDE
10705034576398 - N/A2024-02-12 MODIFIED INSTRUMENT IMPACTOR
10705034000862 - NA2024-02-05 SPINAL INSTRUMENT TROCAR
10705034005195 - KANEDA SR2024-02-05 KANEDA SR ANTERIOR SYSTEM STAPLE TROCHAR ASSEMBLY
10705034576084 - N/A2024-01-25 MODIFIED INSTRUMENT SPACER,NUMBER 2 8° x 11mm
10705034576169 - N/A2024-01-25 MODIFIED INSTRUMENT SPACER,NUMBER 1 5° x 7.5mm
10705034576176 - N/A2024-01-25 MODIFIED INSTRUMENT SPACER,NUMBER 5 14° x 20mm

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