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Sierra Summit

FDA UDI

Class II (US FDA UDI)

by Cadwell Industries, Inc.

Identity

Trade Name
Sierra Summit FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
Sierra Summit 2 Ch. Amplifier FDA UDI
Model / Reference
190276-200 FDA UDI
Description
Sierra Summit 2 Ch. Amplifier FDA UDI

Identifiers

Primary DI / UDI-DI
00840067100103 FDA UDI
FDA Product Code
GWQ FDA UDI
GWF FDA UDI
OLT FDA UDI
IKN FDA UDI
JXE FDA UDI
GWE FDA UDI
OLV FDA UDI
GWJ FDA UDI
GZP FDA UDI
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
882.1870 FDA UDI
890.1375 FDA UDI
882.1550 FDA UDI
882.1890 FDA UDI
882.1900 FDA UDI
882.1880 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromyograph

Sierra Summit by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromyograph.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cadwell Industries, Inc.

Sources (1)

  • FDA UDI de15ab7d-63c5-4ac9-b203-bdbd7a4cdd9d 34 fields · synced Jun 9, 2026