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Accordion CoAx Stone Control Device PA1305-01-15

by T H S International, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857252004009 UDI-DIDate6 Jun 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Accordion CoAx Stone Control Device
Generic Name
Ureteropelvic stone filtering catheter
Model / Ref / Catalog
PA1305-01-15
Primary DI / UDI-DI
00857252004009
FDA Product Code
FFL
GMDN Term
Ureteropelvic stone filtering catheter
Device Class
Class II
Regulation Number
876.4680
GUDID distribution status
Not in Commercial Distribution

Properties

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

Other properties (9)

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