F01

FDA UDI

Class I (US FDA UDI)

by Burlington Medical, Llc

Identity

Trade Name: F01 FDA UDI
Generic Name: Radiation shielding apron FDA UDI
Device Name: Custom F01: Frontal Apron with Back Strap and Tie Closure .5mm Burlite Size Extra Small Female , RBF01-XSF FDA UDI
Model / Reference: RBF01-XSF FDA UDI
Description: Custom F01: Frontal Apron with Back Strap and Tie Closure .5mm Burlite Size Extra Small Female , RBF01-XSF FDA UDI

Identifiers

Primary DI / UDI-DI: 00840331248319 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation shielding apron

F01 by Burlington Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation shielding apron.

Palmero Healthcare, LLC — PALMERO HEALTHCARE LLC · Class I
Fast Wrap Apron — Shielding International Inc. · Class I
Palmero Healthcare, LLC — PALMERO HEALTHCARE LLC · Class I
Wolf X-Ray — Flow X-Ray Corp. · Class I
Wolf X-Ray — Flow X-Ray Corp. · Class I
ErgoLite — AADCO MEDICAL, INC. · Class I
Wolf X-Ray — Flow X-Ray Corp. · Class I
Apron and Vest, Men's Medium, Standard Lead — Flow X-Ray Corp. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Burlington Medical, Llc

Sources (1)

FDA UDI ffd668a6-73f3-4990-bb44-6e6540a4ac23 33 fields · synced Jun 8, 2026