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Scoreflex NC Scoring PTCA Catheter 635-154-1U

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06934955936449 UDI-DI Date16 Feb 2022ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Scoreflex NC Scoring PTCA Catheter
Generic Name
Coronary angioplasty balloon catheter, cutting/scoring
Model / Reference
635-154-1U
Primary DI / UDI-DI
06934955936449
PMA Number
FDA Product Code
NWX
GMDN Term
Coronary angioplasty balloon catheter, cutting/scoring
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Cleared under the same submission (P200041)

Show all (12)

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Properties

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

Other properties (9)

  • 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