W114

FDA UDI

Class I (US FDA UDI)

by Burlington Medical, Llc

Identity

Trade Name: W114 FDA UDI
Generic Name: Radiation shielding apron FDA UDI
Device Name: Custom: W114 One Piece Wrap Quick Release Side and Shoulder Closure .25mm Lead Size Large Plus Female FDA UDI
Model / Reference: ULW114-PLUS FDA UDI
Description: Custom: W114 One Piece Wrap Quick Release Side and Shoulder Closure .25mm Lead Size Large Plus Female FDA UDI

Identifiers

Primary DI / UDI-DI: 00197513008095 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

W114 by Burlington Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Burlington Medical, Llc

Sources (1)

FDA UDI 280d5d0d-19ea-4721-a499-e7cf59f076bf 33 fields · synced May 31, 2026