ACTIVA® Therapy

GUDID 00613994353504

EXT 37085-95 ACTIVA RC 8-4 US MKT

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00613994353504
• NIH Device Record Key: 1a01ee1f-be40-478b-9cc9-5f0f3da5b3e8
• Commercial Distribution Discontinuation: 2018-08-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACTIVA® Therapy
• Version Model Number: 37085-95
• 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: 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

Device Dimensions

• Length: 95 Centimeter
• Length: 95 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994353504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

FDA Product Code

• MHY: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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: 2018-10-02
• Device Publish Date: 2014-09-23

On-Brand Devices [ACTIVA® Therapy]

• 00613994353542: EXT 37085-40 ACTIVA RC 8-4 US MKT
• 00613994353528: EXT 37085-60 ACTIVA RC 8-4 US MKT
• 00613994353504: EXT 37085-95 ACTIVA RC 8-4 US MKT
• 00613994099099: EXTN KIT 7482A95 QD LOW IMP/PRFL 95CM AA
• 00613994099082: EXTN KIT 7482A66 QD LOW IMP/PRFL 66CM AA
• 00613994099075: EXTN KIT 7482A51 QD LOW IMP/PRFL 51CM AA
• 00613994099068: EXTN KIT 7482A40 QD LOW IMP/PRFL 40CM AA