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Collimare

FDA UDI

Class II (US FDA UDI)

by Collimare, LLC

Identity

Trade Name
Collimare FDA UDI
Generic Name
Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
Device Name
Collimator, Portable Certified, 125kVp, LED 25W, MX FDA UDI
Model / Reference
CPL-125-MX01-C FDA UDI
Description
Collimator, Portable Certified, 125kVp, LED 25W, MX FDA UDI

Identifiers

Primary DI / UDI-DI
00862005000344 FDA UDI
510(k) Number
K073124 FDA UDI
FDA Product Code
IZX FDA UDI
GMDN Term
Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Manual-aperture-control diagnostic x-ray system collimator, non-motorized

Collimare by Collimare, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual-aperture-control diagnostic x-ray system collimator, non-motorized.

Cleared under the same submission

K073124 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Collimare, LLC

Sources (1)

  • FDA UDI 021c3db2-2beb-4dd6-8e6e-b0042bfeb7bc 34 fields · synced May 31, 2026