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Model 7800EP

by Ivy Biomedical Systems, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816396023680 UDI-DI Date27 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Accelerator system synchronizer
Model / Ref / Catalog
7800EP, 3304-41-15
Primary DI / UDI-DI
00816396023680
FDA product code
DRT
GMDN term
Accelerator system synchronizer
Device class
Class II
Regulation number
870.2300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Other devices from Ivy Biomedical Systems, Inc.

See all devices from Ivy Biomedical Systems, Inc. →

Properties

  • Serial number
  • Manufacturing date

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No