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Avenir UNO 10CSW01525

by Shanghai Wallaby Medical Technologies Co., Inc.

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 Number06970908218293 UDI-DI Date16 Sep 2026ListedStatusListed 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  • Withdrawn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
Avenir UNO
Generic Name
Neurovascular embolization coil
Model / Reference
10CSW01525
Primary DI / UDI-DI
06970908218293
FDA Product Code
KRD, HCG
GMDN Term
Neurovascular embolization coil
Device Class
Class II
Regulation Number
870.3300, 882.5950
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

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Properties

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

Other properties (9)

  • 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