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Sapphire II PRO Balloon Dilatation Catheter 501001012

by OrbusNeich Medical (ShenZhen) Co., Ltd.

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 Number06934955950032 UDI-DI Date23 Apr 2020ListedStatusListed 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  • Withdrawn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
Sapphire II PRO Balloon Dilatation Catheter
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Reference
501001012
Primary DI / UDI-DI
06934955950032
FDA Product Code
LOX, LIT
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.5100, 870.1250
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 1 Millimeter
Balloon Length — 10 Millimeter

Related devices

Category: Peripheral angioplasty balloon catheter, basicCoronary angioplasty balloon catheter, basic

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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