C-STEM 961246000

GUDID 10603295236351

C-STEM CENTRALISER

DEPUY INTERNATIONAL LTD

Femoral stem centralizer

• Primary Device ID: 10603295236351
• NIH Device Record Key: 52e49646-eec3-4831-b7bd-cfc44c9a535e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-STEM
• Version Model Number: 9612-46-000
• Catalog Number: 961246000
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295236351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982918

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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: 2024-02-05
• Device Publish Date: 2015-09-24

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