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Rochester

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name
Rochester FDA UDI
Generic Name
Analytical scalp electrode, single-use FDA UDI
Device Name
Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.5 m, SINGLE, PVC WIRE, 12/PACK FDA UDI
Model / Reference
DE-C55636-12 FDA UDI
Description
Disposable XS AgCl Deep Cup Electrodes: 6 mm AgCl DISC, 1.5 m, SINGLE, PVC WIRE, 12/PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00849593025522 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

Yes

FDA UDI

Category: Analytical scalp electrode, single-use

Rochester by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analytical scalp electrode, single-use.

Cleared under the same submission

K072016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advantage Medical Electronics, LLC

Sources (1)

  • FDA UDI 4ffb4ebc-b1a2-4e04-8057-ce83e457d96a 34 fields · synced Jun 8, 2026