ARTISAN™ SPACE MAINTENANCE SYSTEM

GUDID 00613994802538

MESH 7000040 TITANIUM

MEDTRONIC SOFAMOR DANEK, INC.

Multi-purpose surgical mesh, metallic

• Primary Device ID: 00613994802538
• NIH Device Record Key: a62a4727-6c75-495c-b962-f373dd75405f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTISAN™ SPACE MAINTENANCE SYSTEM
• Version Model Number: 7000040
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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	00613994802538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100779

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

Moist Heat or Steam Sterilization

[00613994802538]

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: 2015-07-20

On-Brand Devices [ARTISAN™ SPACE MAINTENANCE SYSTEM]

• 00613994802538: MESH 7000040 TITANIUM
• 20613994799801: SOCKET SCREWS 7341218 1.2X18MM 3/4
• 20613994799795: SOCKET SCREWS 7341220 1.2X20MM 3/4
• 20613994799788: SOCKET SCREWS 7341418 1.4X18MM 3/4
• 20613994799771: SOCKET SCREWS 7341420 1.4X20MM 3/4
• 20613994799764: SOCKET SCREWS 7451214 1.2X14MM 4/5
• 20613994799757: SOCKET SCREWS 7451216 1.2X16MM 4/5
• 20613994799740: SOCKET SCREWS 7451218 1.2X18MM 4/5
• 20613994799733: SOCKET SCREWS 7451220 1.2X20MM 4/5
• 20613994799726: SOCKET SCREWS 7451418 1.4X18MM 4/5
• 20613994799719: SOCKET SCREWS 7451420 1.4X20MM 4/5
• 20613994799702: SOCKET SCREWS 7561214 1.2X14MM 5/6
• 20613994799696: SOCKET SCREWS 7561216 1.2X16MM 5/6
• 20613994799689: SOCKET SCREWS 7561218 1.2X18MM 5/6
• 20613994799672: SOCKET SCREWS 7561220 1.2X20MM 5/6
• 20613994799665: SOCKET SCREWS 7561418 1.4X18MM 5/6
• 20613994799658: SOCKET SCREWS 7561420 1.4X20MM 5/6
• 20613994792383: TENT SCREW 7000017 1.2 MM X 14 MM (4/PK)
• 20613994792376: TENT SCREW 7000016 1.2 MM X 12 MM (4/PK)
• 20613994792369: TENT SCREW 7000015 1.2 MM X 10 MM (4/PK)
• 20613994792352: TENT SCREW 7000014 1.2 MM X 8 MM (4/PK)
• 20613994792345: TENT SCREW 7000007 1.4 MM X 14 MM (4/PK)
• 20613994792338: TENT SCREW 7000006 1.4 MM X 12 MM (4/PK)
• 20613994792321: TENT SCREW 7000005 1.4 MM X 10 MM (4/PK)
• 20613994792314: TENT SCREW 7000004 1.4 MM X 8 MM (4/PK)
• 20613994792291: RESCUE SCREW 7000058 1.4MMX7MM 6PK
• 20613994792284: RESCUE SCREW 7000057 1.4MMX5MM 6PK
• 20613994792277: RESCUE SCREW 7000056 1.4MMX3MM 6PK
• 20613994792260: SELF DRILL SCREW 7000055 1.2MMX14MM 6PK
• 20613994792253: SELF DRILL SCREW 7000054 1.2MMX12MM 6PK
• 20613994792246: SELF DRILL SCREW 7000053 1.2MMX10MM 6PK
• 20613994792239: SELF DRILL SCREW 7000052 1.2MMX8MM 6PK
• 20613994792222: SELF DRILL SCREW 7000051 1.2MMX6MM 6PK
• 20613994792215: SELF DRILL SCREW 7000050 1.2MMX4MM 6PK