SPECIFY

GUDID 00613994457219

LEAD 3998 SPECIFY 20 CM US MKT

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead

• Primary Device ID: 00613994457219
• NIH Device Record Key: 58b23188-9897-4b80-b867-4703aac59c22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECIFY
• Version Model Number: 3998
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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: 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

Device Dimensions

• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994457219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [SPECIFY]

• 00613994560322: LEAD 39565-65 SURGICAL LEAD US MNPRO
• 00613994560315: LEAD 39286-65 2X8 SURGICAL LEAD US MNPRO
• 00613994560308: LEAD 39286-30 2X8 SURGICAL LEAD US MNPRO
• 00613994457219: LEAD 3998 SPECIFY 20 CM US MKT
• 00613994287694: LEAD SCS 39565-30 5-6-5 SURGICAL MNPRO