136568000

GUDID 10603295034261

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 48mm +1.5 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295034261
• NIH Device Record Key: 1e3b800d-69fe-4efd-b50e-d1c010b72bdf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1365-68-000
• Catalog Number: 136568000
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295034261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060031

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

Devices Manufactured by DEPUY (IRELAND)

• 10603295079682 - TRUMATCH: 2024-11-07 XRAY POSITIONER
• 10603295383239 - TRUMATCH: 2024-11-07 XRAY POSITIONER CUSHION
• 10603295224266 - SPECIALIST: 2024-09-06 SPECIALIST 2 MI PATELLA WAFER
• 10603295225256 - SIGMA: 2024-09-06 SIGMA HIGH PERFORMANCE FEMORAL NOTCH IMPACTOR
• 10603295226031 - SIGMA LCS: 2024-09-06 SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE UNIVERSAL HANDLE
• 10603295226055 - SIGMA LCS: 2024-09-06 SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE SLAP HAMMER
• 10603295227175 - SIGMA LCS HIGH PERFORMANCE: 2024-09-06 SIGMA LCS HIGH PERFORMANCE PATELLA WAFER LARGE
• 10603295227182 - SIGMA LCS HIGH PERFORMANCE: 2024-09-06 SIGMA LCS HIGH PERFORMANCE PATELLA WAFER SM