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Guardian Probe Extension Ball Tip, 12 cm

FDA UDI

Class II (US FDA UDI)

by Checkpoint Surgical, Inc.

Identity

Trade Name
Guardian Probe Extension Ball Tip, 12 cm FDA UDI
Generic Name
Nerve-locating system FDA UDI
Device Name
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators FDA UDI
Model / Reference
9505 FDA UDI
Description
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators FDA UDI

Identifiers

Catalog Number
9505 FDA UDI
Primary DI / UDI-DI
B13095050 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

Guardian Probe Extension Ball Tip, 12 cm 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 c12f1da7-0951-474b-b5d4-863dd6efa29c 36 fields · synced Jun 6, 2026