SIGMA 950501019

GUDID 10603295224235

SIGMA SP2 MI TIBIAL CUTTING GUIDE 3 DEGREE

DEPUY INTERNATIONAL LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10603295224235
• NIH Device Record Key: 75ea136e-5583-4992-a82a-9fde908980f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA
• Version Model Number: 9505-01-019
• Catalog Number: 950501019
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295224235 [Primary]

FDA Product Code

• HTZ: INSTRUMENT, CUTTING, ORTHOPEDIC

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

[10603295224235]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-05-03
• Device Publish Date: 2015-03-24

On-Brand Devices [SIGMA]

• 10603295230021: SIGMA 150 MICRO CASE
• 10603295229827: SIGMA CR 150 FEMORAL TRIAL CASE
• 10603295229810: SIGMA 150 CLASSIC FEMORAL PREP CASE
• 10603295229803: SIGMA 150 FIXED REFERENCE FEMORAL PREP CASE
• 10603295224242: SIGMA SP2 MI INSTRUMENT TRAY
• 10603295230014: SIGMA 150 MACRO CASE
• 10603295155508: SIGMA RP-F NON POROUS FEMUR TRIAL SIZE 4N RIGHT
• 10603295155492: SIGMA RP-F NON POROUS FEMUR TRIAL SIZE 4N LEFT
• 10603295155461: SIGMA CR150 FEM TRIAL SIZE 4N RIGHT
• 10603295155454: SIGMA CR150 FEM TRIAL SIZE 4N LEFT
• 10603295155447: SIGMA CR150 FEM TRIAL SIZE 6 RIGHT
• 10603295155430: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 4 RIGHT
• 10603295155423: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 5 RIGHT
• 10603295155416: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 3 RIGHT
• 10603295155409: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 2.5 RIGHT
• 10603295155393: SIGMA CR150 FEM TRIAL SIZE 2 RIGHT
• 10603295155386: SIGMA CR150 FEM TRIAL SIZE 1.5 RIGHT
• 10603295155362: SIGMA CR150 FEM TRIAL SIZE 6 LEFT
• 10603295155355: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 5 LEFT
• 10603295155348: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 4 LEFT
• 10603295155331: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 3 LEFT
• 10603295155324: SIGMA HIGH PERFORMANCE CR150 FEM TRIAL SIZE 2.5 LEFT
• 10603295155317: SIGMA CR150 FEM TRIAL SIZE 2 LEFT
• 10603295155300: SIGMA CR150 FEM TRIAL SIZE 1.5 LEFT
• 10603295225430: SIGMA HIGH PERFORMANCE DISTAL FEMORAL CONNECTOR
• 10603295226369: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 6
• 10603295226352: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 5
• 10603295226345: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 4N
• 10603295226338: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 4
• 10603295226321: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 3
• 10603295226314: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 2.5
• 10603295226307: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 2
• 10603295226291: SIGMA HIGH PERFROMANCE CR150 POSTERIOR OSTEOPHYTE REMOVAL GUIDE SZ 1.5
• 10603295226079: SIGMA HIGH PERFORMANCE RECUT KIT SLOT ADAPTOR
• 10603295226062: SIGMA HIGH PERFORMANCE RECUT KIT REFERENCE ARM
• 10603295226024: SIGMA HIGH PERFORMANCE POSTERIOR UP CONVERTER
• 10603295226017: SIGMA HIGH PERFORMANCE ANTERIOR DOWN CONVERTER
• 10603295225997: SIGMA HIGH PERFORMANCE RECUT BLOCK RIGHT 2 DEGREES V / V
• 10603295225980: SIGMA HIGH PERFORMANCE RECUT BLOCK LEFT 2 DEGREES V / V
• 10603295225973: SIGMA HIGH PERFORMANCE RECUT BLOCK +3 DEGREES
• 10603295225966: SIGMA HIGH PERFORMANCE RECUT BLOCK +2mm
• 10603295225959: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 6
• 10603295225942: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 5
• 10603295225935: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 4
• 10603295225928: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 3
• 10603295225911: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 2.5
• 10603295225904: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 2
• 10603295225898: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 1.5
• 10603295225881: SIGMA HIGH PERFORMANCE RP-F FEMORAL FINISHING BLOCK SZ 1
• 10603295225874: SIGMA HIGH PERFORMANCE FEMORAL FINISHING BLOCK SZ 6