Rochester

GUDID 00849593025539

Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.0 m, SINGLE, PVC WIRE, 25/PACK

Advantage Medical Electronics, LLC

Analytical scalp electrode, single-use

• Primary Device ID: 00849593025539
• NIH Device Record Key: e13bfeca-1ecf-4ea6-903d-ef4042577972
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rochester
• Version Model Number: DE-C55438-25
• Company DUNS: 080242300
• Company Name: Advantage Medical Electronics, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849593025539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072016

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

On-Brand Devices [Rochester]

• 00849593025416: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 30 GA, 25MM NEEDLE, RED
• 00849593025393: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 27 GA, 25MM NEEDLE, YELLOW
• 00849593025379: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 26 GA, 50MM NEEDLE, BLUE
• 00849593025348: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 26 GA, 37MM NEEDLE, GREEN
• 00849593025355: DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 23 GA, 75MM NEEDLE, VIOLET
• 00849593025317: REUSABLE SHIELDED CABLE, FOR CONCENTRIC + SINGLE FIBER EMG NEEDLE ELECTRODE, 2.0M (6.5FT), 5 POL
• 00849593025300: REUSABLE SHIELDED CABLE, FOR CONCENTRIC + SINGLE FIBER EMG NEEDLE ELECTRODE, 1.25M (4FT), 5 POLE
• 00849593025560: Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 2.5 m, SINGLE, PVC WIRE, 10/PACK
• 00849593025553: Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 2.5 m, SINGLE, PVC WIRE, 25/PACK
• 00849593025546: Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.5 m, SINGLE, PVC WIRE, 25/PACK
• 00849593025539: Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.0 m, SINGLE, PVC WIRE, 25/PACK
• 00849593025522: Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.5 m, SINGLE, PVC WIRE, 12/PACK
• 00849593025515: Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.0 m, SINGLE, PVC WIRE, 12/PACK