Rochester

GUDID 00849593015769

DISPOSABLE EEG CUP ELECTRODES: 9 MM STAMPED TIN DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE

AMC

Analytical scalp electrode, single-use

• Primary Device ID: 00849593015769
• NIH Device Record Key: 555bee86-8ca3-4ff1-93f8-de288c13959e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rochester
• Version Model Number: DE-001834-4
• Company DUNS: 080242300
• Company Name: AMC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849593015769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142159

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: 2019-04-18
• Device Publish Date: 2019-04-10

On-Brand Devices [Rochester ]

• 00849593015554: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 6 FT (1.8 M) WIRES.
• 00849593015479: REUSABLE EAR CLIP ELECTRODES: 9 MM GOLD DISC, 6 FT. (1.8 M), PVC WIRE
• 00849593009973: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M MULTILEAD LEAD
• 00849593009911: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M TWISTED LEADWI
• 00849593009898: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWI
• 00849593009850: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M SINGLE LEADWIR
• 00849593015769: DISPOSABLE EEG CUP ELECTRODES: 9 MM STAMPED TIN DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE
• 00849593015493: REPLACEMENT STAMPED ELECTRODE DISCS: 9 MM STAMPED TIN DISCS
• 00849593009874: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 19 MM NEEDLE, 1.5 M SINGLE LEADWIR
• 00849593010078: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 1.5 M SINGLE LE
• 00849593010054: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 2.5 M SINGLE LEADWIRE
• 00849593010023: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 1.5 M SINGLE LEADWIRE
• 00849593009997: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M MULTILEAD LEAD
• 00849593009935: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M MULTILEAD LEAD
• 00849593015486: REPLACEMENT STAMPED ELECTRODE DISCS: 6 MM STAMPED TIN DISCS
• 00849593015240: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 2.5 M SINGLE LE
• 00849593009959: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M MULTILEAD LEAD
• 00849593009836: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M SINGLE LEADWIR
• 00849593015745: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 30" (0.76 M)
• 00849593015721: 9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED WIRE