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Coupler M2050

by EBR Systems, Inc.

Coupler M2050 is a Class I device made by EBR Systems, Inc., listed in FDA GUDID since 8 Jul 2026 (UDI-DI 00859244007081), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859244007081 UDI-DI Date8 Jul 2026ListedStatusListed 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  • Withdrawn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
Coupler
Generic name
Cardiac implantation catheter holder, single-use
Model / reference
M2050
Primary DI / UDI-DI
00859244007081
FDA product code
QWA
GMDN term
Cardiac implantation catheter holder, single-use
Device class
Class I
Regulation number
870.3955
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QWA (Cardiovascular Delivery Catheter System Positioning And Stabilization Device).

Other devices from EBR Systems, Inc.

See all devices from EBR Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)