C-STEM 961172000

GUDID 10603295235279

C-STEM Stem High Offset SIZE 4 9/10 TAPER CEMENTED

DEPUY (IRELAND)

Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular Uncoated hip femur prosthesis, modular

• Primary Device ID: 10603295235279
• NIH Device Record Key: 3396e96c-569a-4bb4-80a6-6cb57c8af661
• Commercial Distribution Discontinuation: 2022-07-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-STEM
• Version Model Number: 9611-72-000
• Catalog Number: 961172000
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• 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
• 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	10603295235279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982918

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-22
• Device Publish Date: 2015-09-24

On-Brand Devices [C-STEM]

• 10603295060369: C-STEM AMT Cemented Stem High Offset Size 8 12/14 TAPER
• 10603295060352: C-STEM AMT Cemented Stem High Offset Size 7 12/14 TAPER
• 10603295060345: C-STEM AMT Cemented Stem High Offset Size 6 12/14 TAPER
• 10603295060338: C-STEM AMT Cemented Stem High Offset Size 5 12/14 TAPER
• 10603295060321: C-STEM AMT Cemented Stem High Offset Size 4 12/14 TAPER
• 10603295060307: C-STEM AMT Cemented Stem High Offset Size 3 12/14 TAPER
• 10603295060291: C-STEM AMT Cemented Stem High Offset Size 2 12/14 TAPER
• 10603295060284: C-STEM AMT Cemented Stem High Offset SIZE 1 12/14 TAPER
• 10603295059677: C-STEM AMT Cemented Stem Standard Offset Size 8 12/14 TAPER
• 10603295059660: C-STEM AMT Cemented Stem Standard Offset Size 7 12/14 TAPER
• 10603295059653: C-STEM AMT Cemented Stem Standard Offset Size 6 12/14 TAPER
• 10603295059646: C-STEM AMT Cemented Stem Standard Offset Size 5 12/14 TAPER
• 10603295059639: C-STEM AMT Cemented Stem Standard Offset Size 4 12/14 TAPER
• 10603295059615: C-STEM AMT Cemented Stem Standard Offset Size 3 12/14 TAPER
• 10603295059608: C-STEM AMT Cemented Stem Standard Offset Size 2 12/14 TAPER
• 10603295059592: C-STEM AMT Cemented Stem Standard Offset SIZE 1 12/14 TAPER
• 10603295236849: C-STEM Stem High Offset SIZE 2 9/10 TAPER CEMENTED
• 10603295236801: C-STEM Revision Stem - Length 240mm SIZE 8 9/10 TAPER CEMENTED
• 10603295236795: C-STEM Revision Stem - Length 200mm SIZE 8 9/10 TAPER CEMENTED
• 10603295236788: C-STEM Revision Stem - Length 240mm SIZE 6 9/10 TAPER CEMENTED
• 10603295236771: C-STEM Revision Stem - Length 200mm SIZE 6 9/10 TAPER CEMENTED
• 10603295236764: C-STEM Revision Stem - Length 240mm SIZE 4 9/10 TAPER CEMENTED
• 10603295236757: C-STEM Revision Stem - Length 200mm SIZE 4 9/10 TAPER CEMENTED
• 10603295235286: C-STEM Stem High Offset SIZE 5 9/10 TAPER CEMENTED
• 10603295235279: C-STEM Stem High Offset SIZE 4 9/10 TAPER CEMENTED
• 10603295235262: C-STEM Stem High Offset SIZE 3 9/10 TAPER CEMENTED
• 10603295235255: C-STEM Stem SIZE 8 9/10 TAPER CEMENTED
• 10603295235248: C-STEM Stem SIZE 7 9/10 TAPER CEMENTED
• 10603295235231: C-STEM Stem SIZE 6 9/10 TAPER CEMENTED
• 10603295235224: C-STEM Stem SIZE 5 9/10 TAPER CEMENTED
• 10603295235217: C-STEM Stem SIZE 4 9/10 TAPER CEMENTED
• 10603295235200: C-STEM Stem SIZE 3 9/10 TAPER CEMENTED
• 10603295235194: C-STEM Stem SIZE 2 9/10 TAPER CEMENTED
• 10603295235187: C-STEM Stem SIZE 1 9/10 TAPER CEMENTED
• 10603295235170: C-STEM Stem SIZE CDH 9/10 TAPER CEMENTED