Identity
- Trade Name
- GoldSelect™ FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE, 10/PACK FDA UDI
- Model / Reference
- DGE-48 FDA UDI
- Description
- Disposable GoldSelect™ Cup Electrodes: 9MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE, 10/PACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849593025201 FDA UDI
- 510(k) Number
- K072016 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Analytical scalp electrode, single-use
GoldSelect™ by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analytical scalp electrode, single-use.
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Cleared under the same submission
K072016 also covers:
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- GoldSelect™ — Advantage Medical Electronics, LLC
- Rochester — Advantage Medical Electronics, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advantage Medical Electronics, LLC
Sources (1)
- FDA UDI 865fff44-cc86-4cc6-abf2-7802ebe693b7 34 fields · synced May 30, 2026