Guardian Intraoperative Lead, Medium

FDA UDI

Class II (US FDA UDI)

by Checkpoint Surgical, Inc.

Identity

Trade Name: Guardian Intraoperative Lead, Medium FDA UDI
Generic Name: Nerve-locating system FDA UDI
Device Name: The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm. FDA UDI
Model / Reference: 9525 FDA UDI
Description: The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm. FDA UDI

Identifiers

Catalog Number: 9525 FDA UDI
Primary DI / UDI-DI: B13095250 FDA UDI
510(k) Number: K212355 FDA UDI
FDA Product Code: PDQ FDA UDI
ETN FDA UDI
GMDN Term: Nerve-locating system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 7 Millimeter FDA UDI

Category: Nerve-locating system

Guardian Intraoperative Lead, Medium by Checkpoint Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K212355 also covers:

Guardian Intraoperative Lead, Small — Checkpoint Surgical, Inc.

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

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Manufacturer

Manufacturer: Checkpoint Surgical, Inc.

Sources (1)

FDA UDI 108c8273-09f4-428e-ad34-bfcbfd1384b4 37 fields · synced May 30, 2026