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ComfortLite

FDA UDI

Class I (US FDA UDI)

by Aadco Medical, Inc.

Identity

Trade Name
ComfortLite FDA UDI
Generic Name
Radiation shielding apron FDA UDI
Device Name
.35MM LEADFREE COMFORTLITE VEST SMALL MALE CUSTOM FDA UDI
Model / Reference
LP-CF680 FDA UDI
Description
.35MM LEADFREE COMFORTLITE VEST SMALL MALE CUSTOM FDA UDI

Identifiers

Catalog Number
LP-CF680 FDA UDI
Primary DI / UDI-DI
00840348516722 FDA UDI
FDA Product Code
EAJ FDA UDI
GMDN Term
Radiation shielding apron FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation shielding apron

ComfortLite by Aadco Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation shielding apron.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aadco Medical, Inc.

Sources (1)

  • FDA UDI da009d0a-378b-463f-9adb-3be7bd933885 34 fields · synced Jun 8, 2026