GUDID 00613994284587

MESH CMESH-3WK CUSTOM 3WK IMPLANT

MEDTRONIC PS MEDICAL, INC.

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 00613994284587
• NIH Device Record Key: 2705eb05-7485-4c6a-bb8a-65314b2159d4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CMESH-3WK
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994284587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974017

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

[00613994284587]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-24

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

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• 00763000422677 - Snap Shunt Assembly, StrataMR II, Regular: 2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE
• 00763000422691 - Unassembled Shunt Kit, StrataMR II, Regular: 2025-01-31 KIT 46967MR UNASSY SHNT SMR II REG CE
• 00763000422738 - StrataMR II: 2025-01-15 ASSY 46965MR SHUNT STRATAMR II REGULAR
• 00763000422752 - StrataMR II: 2025-01-15 SHUNT 46966MR SNP ASSY STRATAMR II REG
• 00763000422776 - StrataMR II: 2025-01-15 KIT 46967MR UNASSY SHNT STRATAMR II REG
• 00763000333461 - Exacta™: 2024-12-23 EDMS 27579 EXACTA W/ PATIENT LINE Y-PORT
• 00763000333478 - Exacta™: 2024-12-23 KIT 27581 EXACTA W/EDM VCATH 35CM