C-STEM 258000115

GUDID 10603295490579

C-STEM AMT BROACH SIZE 1

DEPUY INTERNATIONAL LTD

Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach

• Primary Device ID: 10603295490579
• NIH Device Record Key: 71c71d0b-6498-4ffe-a4a7-a0445862997a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-STEM
• Version Model Number: 2580-00-115
• Catalog Number: 258000115
• 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
• 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	10603295490579 [Primary]

FDA Product Code

• QBO: Instruments designed for press-fit osteochondral implants

Sterilization

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

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

[10603295490579]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [C-STEM]

• 10603295235453: C-STEM CANAL REAMER 20MM
• 10603295235446: C-STEM CANAL REAMER 19MM
• 10603295235439: C-STEM CANAL REAMER 18MM
• 10603295235422: C-STEM CANAL REAMER 17MM
• 10603295235408: C-STEM CANAL REAMER 16MM
• 10603295235385: C-STEM CANAL REAMER 15MM
• 10603295235361: C-STEM CANAL REAMER 14MM
• 10603295235347: C-STEM CANAL REAMER 13MM
• 10603295235330: C-STEM CANAL REAMER 12MM
• 10603295235323: C-STEM CANAL REAMER 11MM
• 10603295235316: C-STEM CANAL REAMER 10MM
• 10603295235309: C-STEM CANAL REAMER 9MM
• 10603295235293: C-STEM CANAL REAMER 8MM
• 10603295490654: C-STEM AMT INCEMENT TRAY
• 10603295478409: C-STEM AMT REVISION TRAY
• 10603295235903: C-STEM INSTRUMENT CASE COMPLETE
• 10603295147855: C-Stem AMT TRAY 2
• 10603295147848: C-Stem AMT TRAY 1
• 10603295478423: C-STEM AMT EXTENDED TRAY
• 10603295478416: C-STEM AMT CORE TRAY
• 10603295490647: C-STEM AMT BROACH SIZE 8
• 10603295490630: C-STEM AMT BROACH SIZE 7
• 10603295490623: C-STEM AMT BROACH SIZE 6
• 10603295490616: C-STEM AMT BROACH SIZE 5
• 10603295490609: C-STEM AMT BROACH SIZE 4
• 10603295490593: C-STEM AMT BROACH SIZE 3
• 10603295490586: C-STEM AMT BROACH SIZE 2
• 10603295490579: C-STEM AMT BROACH SIZE 1
• 10603295490562: C-STEM AMT BROACH SIZE 3A
• 10603295490555: C-STEM AMT BROACH SIZE 2A
• 10603295490548: C-STEM AMT BROACH SIZE 1A
• 10603295490531: C-STEM AMT BROACH SIZE CDH
• 10603295235859: C-STEM NECK SEGMENT SIZE 5 HI
• 10603295235828: C-STEM NECK SEGMENT SIZE 4 HI
• 10603295235781: C-STEM NECK SEGMENT SIZE 3 HI
• 10603295235743: C-STEM NECK SEGMENT SIZE 2 HI
• 10603295235668: C-STEM NECK RESECTION GUIDE
• 10603295147831: C-Stem TO C-Stem AMT CONVERSION TRAY
• 10603295147824: C-Stem AMT BROACH INSTRUMENT TRAY
• 10603295147800: C-STEM TO AMT HIGH NECK SEGMENT SIZE 8
• 10603295147794: C-STEM TO AMT HIGH NECK SEGMENT SIZE 7
• 10603295147787: C-STEM TO AMT HIGH NECK SEGMENT SIZE 6
• 10603295147770: C-STEM TO AMT HIGH NECK SEGMENT SIZE 5
• 10603295147763: C-STEM TO AMT HIGH NECK SEGMENT SIZE 4
• 10603295147756: C-STEM TO AMT HIGH NECK SEGMENT SIZE 3
• 10603295147749: C-STEM TO AMT HIGH NECK SEGMENT SIZE 2
• 10603295147732: C-STEM TO AMT HIGH NECK SEGMENT SIZE 1
• 10603295147725: C-STEM TO AMT STD NECK SEGMENT SIZE 8
• 10603295147718: C-STEM TO AMT STD NECK SEGMENT SIZE 7
• 10603295147701: C-STEM TO AMT STD NECK SEGMENT SIZE 6