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Sunmed™ guide wires J-tip, 0.035"x200cm, PTFE Coated

by Sunny Medical Device (Shenzhen) Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06947358524021 UDI-DIDate7 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
Sunmed™ guide wires
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Model / Reference
J-tip, 0.035"x200cm, PTFE Coated
Primary DI / UDI-DI
06947358524021
510(k) Number
FDA Product Code
DQX
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class II
Regulation Number
870.1330
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K120119)

Other devices from Sunny Medical Device (Shenzhen) Co., Ltd.

See all devices from Sunny Medical Device (Shenzhen) Co., Ltd. →

Properties

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

Other properties (10)

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