GoldSelect™
GUDID 00849593025607
DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE, 10/ELECTRODES
Advantage Medical Electronics, LLC
Analytical scalp electrode, single-use| Primary Device ID | 00849593025607 |
| NIH Device Record Key | 5c51eac7-3811-4aed-94a6-5e78d53a0df1 |
| Commercial Distribution Discontinuation | 2024-07-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GoldSelect™ |
| Version Model Number | DE-003748-VA |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com | |
| Phone | 954-345-9800 |
| info@advantagemed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849593025607 [Primary] |
| GS1 | 10849593025604 [Package] Package: Box [25 Units] In Commercial Distribution |
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 | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
Devices Manufactured by Advantage Medical Electronics, LLC
| 00849593025584 - AMC | 2024-11-06 3 Lead Reusable NK to Pinch, Shield, 29" AHA |
| 10849593025499 - AMC | 2024-11-01 5 Lead Disposable Philips MX40 with SpO2 to PINCH, SHLD, 29", AHA |
| 00849593025638 - AMC | 2024-11-01 5 Lead Reusable YokeMate Adapter, MX40 to PH w/M SpO2 |
| 00849593025607 - GoldSelect™ | 2024-07-18DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE, 10/ELECTRODES |
| 00849593025607 - GoldSelect™ | 2024-07-18 DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE, 10/ELECTRODES |
| 00849593025515 - Rochester | 2024-07-16 Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.0 m, SINGLE, PVC WIRE, 12/PACK |
| 00849593025522 - Rochester | 2024-07-16 Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.5 m, SINGLE, PVC WIRE, 12/PACK |
| 00849593025539 - Rochester | 2024-07-16 Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.0 m, SINGLE, PVC WIRE, 25/PACK |
| 00849593025546 - Rochester | 2024-07-16 Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.5 m, SINGLE, PVC WIRE, 25/PACK |
Trademark Results [GoldSelect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GOLDSELECT 88760912 not registered Live/Pending |
General Nutrifoods Philippines, Inc. 2020-01-15 |
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