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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 non-scalp cutaneous lead FDA UDI
Device Name
9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED WIRE FDA UDI
Model / Reference
AC-032238 FDA UDI
Description
9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED WIRE FDA UDI

Identifiers

Primary DI / UDI-DI
00849593015721 FDA UDI
510(k) Number
K142159 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Analytical non-scalp cutaneous lead 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

No

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 non-scalp cutaneous lead

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

Similar devices

Also classified as Analytical non-scalp cutaneous lead.

Cleared under the same submission

K142159 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 d8f17d57-a995-4e61-abbd-fef0d84985ca 35 fields · synced May 31, 2026