SIGMA HIGH PERFORMANCE 950502060

GUDID 10603295227762

SIGMA HIGH PERFORMANCE FBT DRILL TOWER

DEPUY ORTHOPAEDICS, INC.

Surgical drill guide, reusable
Primary Device ID10603295227762
NIH Device Record Key44de3e58-8866-430c-b064-9d9db8715af9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIGMA HIGH PERFORMANCE
Version Model Number9505-02-060
Catalog Number950502060
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295227762 [Primary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10603295227762]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-06
Device Publish Date2018-09-24

On-Brand Devices [SIGMA HIGH PERFORMANCE]

10603295227762SIGMA HIGH PERFORMANCE FBT DRILL TOWER
10603295229773SIGMA HIGH PERFORMANCE FIXED BEARING THICK INSERT TRIAL CASE
10603295229766SIGMA HIGH PERFORMANCE ROTATING PLATFORM THICK INSERT TRIAL CASE
10603295229544SIGMA HIGH PERFORMANCE FB CURVED PLUS INSERT TRIALS CASE
10603295227700SIGMA HIGH PERFORMANCE FBT EVALUATION BULLET SIZE 4-6
10603295227694SIGMA HIGH PERFORMANCE FBT EVALUATION BULLET SIZE 1.5-3
10603295228837SIGMA HIGH PERFORMANCE ANTERIOR FIRST REMOVABLE STYLUS
10603295227786SIGMA HIGH PERFORMANCE FBT STANDARD TIBIAL PUNCH GUIDE SIZE 5-6
10603295227779SIGMA HIGH PERFORMANCE FBT STANDARD TIBIAL PUNCH GUIDE SIZE 1.5-4

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