GoldSelect™

GUDID 00849593025157

Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 10 FT. (3.5 M), SINGLE, PVC WIRE, 10/PACK

AMC

Analytical scalp electrode, single-use

• Primary Device ID: 00849593025157
• NIH Device Record Key: 335c2705-c81d-4dae-9901-a996e1dc33af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoldSelect™
• Version Model Number: DE-003710
• Company DUNS: 080242300
• Company Name: AMC
• Device Count: 1
• DM Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849593025157 [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: 2022-11-28
• Device Publish Date: 2022-11-20

On-Brand Devices [GoldSelect™]

• 00849593025249: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE,
• 00849593025232: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 10 FT. (3.5 M), SINGLE, PVC WIRE
• 00849593025225: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC WIRE,
• 00849593025201: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE,
• 00849593025195: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE,
• 00849593025188: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC WIRE,
• 00849593025171: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE,
• 00849593025164: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE,
• 00849593025157: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 10 FT. (3.5 M), SINGLE, PVC WIRE
• 00849593025140: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC WIRE,
• 00084959302521: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE,
• 00849593025133: Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE,