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Dualview Tu-DSS01C

by Terumo Corp.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987350744487 UDI-DI Date21 Jan 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  • Withdrawn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

Trade Name
Dualview
Generic Name
Intravascular ultrasound imaging catheter, single-use
Model / Ref / Catalog
TU-DSS01C, TU*DV01U
Primary DI / UDI-DI
04987350744487
FDA Product Code
DQO
GMDN Term
Intravascular ultrasound imaging catheter, single-use
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Terumo Corp.

See all devices from Terumo Corp. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No