ACCUGUIDE®

GUDID 20643169344994

NEEDLE 8263210 5PK 30G W/ELECTRODE ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system Nerve-locating system

• Primary Device ID: 20643169344994
• NIH Device Record Key: ead0ebb3-3c69-4c0d-b8f2-7db613c4e9d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUGUIDE®
• Version Model Number: 8263210
• 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: 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

• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169344990 [Primary]
GS1	20643169344994 [Package]; Contains: 00643169344990; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990793

FDA Product Code

• GXZ: ELECTRODE, NEEDLE

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: 2018-07-06
• Device Publish Date: 2016-04-22

On-Brand Devices [ACCUGUIDE®]

• 00613994161635: SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
• 20643169345007: NEEDLE 8263211 5PK 27G W/ELECTRODE ROHS
• 20643169344994: NEEDLE 8263210 5PK 30G W/ELECTRODE ROHS