GUDID 00613994871510

ELECTRODE SRE1002 SD SURFACE RECORD ROHS

MEDTRONIC XOMED, INC.

Subdermal needle electrode

• Primary Device ID: 00613994871510
• NIH Device Record Key: fe568dc5-ce54-4b5d-be40-ae78be009a3b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SRE1002
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: false
• 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

• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994871510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061639

FDA Product Code

• GWJ: STIMULATOR, AUDITORY, EVOKED RESPONSE

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: 2016-05-05

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