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Checkpoint Guardian

FDA UDI

Class II (US FDA UDI)

by Checkpoint Surgical, Inc.

Identity

Trade Name
Checkpoint Guardian FDA UDI
Generic Name
Nerve-locating system FDA UDI
Device Name
Handheld Single-use Surgical Nerve Stimulator FDA UDI
Model / Reference
9095 FDA UDI
Description
Handheld Single-use Surgical Nerve Stimulator FDA UDI

Identifiers

Catalog Number
9095 FDA UDI
Primary DI / UDI-DI
B13090950 FDA UDI
510(k) Number
K092292 FDA UDI
FDA Product Code
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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nerve-locating system

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

Similar devices

Also classified as Nerve-locating system.

Cleared under the same submission

K092292 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Checkpoint Surgical, Inc.

Sources (1)

  • FDA UDI f350ae6e-88b7-4d6f-a648-a53332cfda98 37 fields · synced Jun 1, 2026