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Sq-Rx® Pulse Generator

FDA UDI

Class III (US FDA UDI)

by Cameron Health, Inc.

Identity

Trade Name
SQ-RX® PULSE GENERATOR FDA UDI
Generic Name
Single-chamber implantable defibrillator FDA UDI
Device Name
SQ-RX Pulse Generator FDA UDI
Model / Reference
1010 FDA UDI
Description
SQ-RX Pulse Generator FDA UDI

Identifiers

Primary DI / UDI-DI
00802526562808 FDA UDI
PMA Number
P110042 FDA UDI
FDA Product Code
LWS FDA UDI
GMDN Term
Single-chamber implantable defibrillator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Sq-Rx® Pulse Generator by Cameron Health, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P110042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cameron Health, Inc.

Sources (1)

  • FDA UDI 6961efbb-5e1f-4d65-bcff-2ef6de95fa85 35 fields · synced May 30, 2026