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Royal Flush G58552

by Cook Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00827002585522 UDI-DI Date12 Nov 2020ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Royal Flush
Generic Name
Angiographic catheter, single-use
Model / Ref / Catalog
G58552, HN5.0-38-90-P-10S-CFP-01
Primary DI / UDI-DI
00827002585522
510(k) Number
FDA Product Code
DQO
GMDN Term
Angiographic catheter, single-use
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K180054)

Show all (12)

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

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