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W114 ULW114-Plus

by Burlington Medical, LLC

W114 ULW114-Plus is a Class I device made by Burlington Medical, LLC, listed in FDA GUDID since 8 Feb 2023 (UDI-DI 00197513008095), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197513008095 UDI-DI Date8 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
W114
Generic name
Radiation shielding apron
Model / reference
ULW114-PLUS
Description
Custom: W114 One Piece Wrap Quick Release Side and Shoulder Closure .25mm Lead Size Large Plus Female
Primary DI / UDI-DI
00197513008095
FDA product code
EAJ
GMDN term
Radiation shielding apron
Device class
Class I
Regulation number
892.6500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EAJ (Apron, Leaded).

Other devices from Burlington Medical, LLC

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)