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Beacon

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Beacon FDA UDI
Generic Name
Blood vessel sizer FDA UDI
Device Name
Beacon Tip Centimeter Sizing Catheter FDA UDI
Model / Reference
G31213 FDA UDI
Description
Beacon Tip Centimeter Sizing Catheter FDA UDI

Identifiers

Catalog Number
NR5.0-35-70-P-10S-0-CSC-20 FDA UDI
Primary DI / UDI-DI
00827002312135 FDA UDI
510(k) Number
K173289 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Blood vessel sizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

FDA UDI

Category: Blood vessel sizer

Beacon by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood vessel sizer.

Cleared under the same submission

K173289 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI ab0e0771-7f96-44c1-a70a-7940263abca3 37 fields · synced Jun 8, 2026