136504000

GUDID 10603295032946

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm -2 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295032946
• NIH Device Record Key: d4625b08-4ba3-4a3d-8f86-5c9c0b1151b9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1365-04-000
• Catalog Number: 136504000
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295032946 [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)

• 10603295082415 - NA: 2025-07-09 Marathon XLPE Cemented Cup T-Handle
• 10603295221845 - NA: 2025-07-09 DePuy MI System IMPACTOR TIP 22.225mm
• 10603295221852 - NA: 2025-07-09 DePuy MI System IMPACTOR TIP 26mm
• 10603295221869 - NA: 2025-07-09 DePuy MI System IMPACTOR TIP 28mm
• 10603295221876 - NA: 2025-07-09 DePuy MI System IMPACTOR TIP 32mm
• 10603295221883 - NA: 2025-07-09 DePuy MI System IMPACTOR TIP 36mm
• 10603295235460 - C-STEM: 2025-07-09 PEG FOR TRIAL C-STEM
• 10603295281573 - NA: 2025-07-09 Marathon XLPE Cemented Cup 36mm Pusher Head