136551000

GUDID 10603295033912

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +1.5

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295033912
• NIH Device Record Key: 96ebc355-2346-490a-b69a-c22590149221
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1365-51-000
• Catalog Number: 136551000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295033912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980513

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: 2020-04-06
• Device Publish Date: 2015-09-24

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• 10603295559443 - INHANCE INTACT: 2025-06-23 INHANCE INTACT OFFSET GLENOID GUIDE
• 10603295559450 - INHANCE INTACT: 2025-06-23 INHANCE INTACT GLENOID DRILL
• 10603295559467 - INHANCE INTACT: 2025-06-23 INHANCE INTACT RESECTION GUIDE EXTENDER
• 10603295559474 - INHANCE INTACT: 2025-06-23 INHANCE INTACT RESECTION GUIDE HANDLE
• 10603295559481 - INHANCE INTACT: 2025-06-23 INHANCE INTACT RESECTION GUIDE LEFT
• 10603295559498 - INHANCE INTACT: 2025-06-23 INHANCE INTACT RESECTION GUIDE RIGHT