CHARNLEY 962340000

GUDID 10603295242208

CHARNLEY STEM ROUNDBACK 45 22.225mm OD HEAD CEMENTED

DEPUY INTERNATIONAL LTD

Uncoated hip femur prosthesis, one-piece

• Primary Device ID: 10603295242208
• NIH Device Record Key: 2e26c7c4-9498-478f-a094-ab3ed5017861
• Commercial Distribution Discontinuation: 2021-12-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CHARNLEY
• Version Model Number: 9623-40-000
• Catalog Number: 962340000
• 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
• 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	10603295242208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802627

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: 2024-11-07
• Device Publish Date: 2015-09-24

On-Brand Devices [CHARNLEY]

• 10603295241683: CHARNLEY CEMENT RESTRICTOR INTRODUCER MODIFIED
• 10603295241812: CHARNLEY RING CURETTE
• 10603295241706: CHARNLEY ACETABULAR SCRAPER
• 10603295240877: CHARNLEY CURETTE LGE
• 10603295240860: CHARNLEY CURETTE MED
• 10603295240853: CHARNLEY CURETTE SML
• 10603295241096: CHARNLEY HAND TAPER REAMER LARGE
• 10603295240662: CHARNLEY HAND TAPER REAMER SMALL
• 10603295241676: CHARNLEY WIRE TIGHTENER
• 10603295240549: CHARNLEY RETRACTOR PINS 10.5CM
• 10603295240532: CHARNLEY PN RETRACT & HANDLE
• 10603295241805: CHARNLEY ACETABULAR BRUSH
• 10603295241720: CHARNLEY PUNCH
• 10603295240808: CHARNLEY NECK OSTEOTOMY GUIDE
• 10603295240648: CHARNLEY SOCKET SIZE GAUGE LARGE
• 10603295240631: CHARNLEY SOCKET SIZE GAUGE SMALL
• 10603295240556: CHARNLEY CENTERING RING MK II
• 10603295241942: CHARNLEY WIRE CUTTERS 10 Inches
• 10603295242338: CHARNLEY Stem Extra Heavy LONG NECK 1 22.225mm OD HEAD CEMENTED
• 10603295242321: CHARNLEY STEM LONG NECK 1 22.225mm OD HEAD CEMENTED
• 10603295242307: CHARNLEY Stem Extra Heavy FLANGED 45 22.225mm OD HEAD CEMENTED
• 10603295242246: CHARNLEY STEM FLANGED 45 22.225mm OD HEAD CEMENTED
• 10603295242208: CHARNLEY STEM ROUNDBACK 45 22.225mm OD HEAD CEMENTED
• 10603295241904: CHARNLEY STEM ROUNDBACK 40 NARROW 22.225mm OD HEAD CEMENTED
• 10603295241898: CHARNLEY STEM ROUNDBACK 40 22.225MM OD HEAD CEMENTED
• 10603295241881: CHARNLEY STEM FLANGED 40 22.225mm OD HEAD CEMENTED
• 10603295241874: CHARNLEY Stem Extra Heavy FLANGED 40 22.225mm OD HEAD CEMENTED
• 10603295240501: CHARNLEY WEIGHT AND 24 INCHES CHAIN