Rochester

GUDID 10816843021211

REPLACEMENT STAMPED ELECTRODE DISCS: 9 MM STAMPED TIN DISCS

ROCHESTER ELECTRO-MEDICAL, INC.

Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable

• Primary Device ID: 10816843021211
• NIH Device Record Key: 3c297cf0-b082-4679-832a-37d6ab1a12cf
• Commercial Distribution Discontinuation: 2019-05-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rochester
• Version Model Number: 00750T-C
• Company DUNS: 068156330
• Company Name: ROCHESTER ELECTRO-MEDICAL, INC.
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816843021211 [Primary]
GS1	10816843021228 [Unit of Use]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-24

On-Brand Devices [Rochester]

• 10816843021211: REPLACEMENT STAMPED ELECTRODE DISCS: 9 MM STAMPED TIN DISCS
• 10816843021198: REPLACEMENT STAMPED ELECTRODE DISCS: 6 MM STAMPED TIN DISCS
• 10816843021174: REUSABLE EAR CLIP ELECTRODES: 9 MM GOLD DISC, 6 FT. (1.8 M), PVC WIRE
• 10816843021150: REUSABLE EAR CLIP ELECTRODES: 9MM SILVER DISC, 6 FT. (1.8 M), PVC WIRE
• 10816843021297: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 6 FT (1.8 M) WIRES
• 10816843023765: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 6 FT (1.8 M) WIRES
• 10816843023741: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 3 FT (0.9 M) WIRES
• 10816843020085: REUSABLE DIGITAL RING ELECTRODES: RED & BLACK, 2 FT. (0.61 M), HEAVY-DUTY WIRE
• 10816843020061: REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 4 FT (1.2 M), HEAVY-
• 10816843020047: REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 30" (0.76 M), HEAVY-
• 10816843020023: REUSABLE FIXED BAR ELECTRODES: 9 MM TIN DISC, 3 CM BETWEEN DISCS, 4 FT. (1.2M), TWISTED WIRE
• 10816843020009: REUSABLE TIN SKIN PICK-UP DISC ELECTRODES: 9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED W