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NeoNavia Biopsy System 1102

by NeoDynamics AB (publ)

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17350081940086 UDI-DI Date20 Mar 2023ListedStatusListed GUDID: not 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  • Withdrawn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
NeoNavia Biopsy System
Generic Name
Mammographic stereotactic biopsy system
Model / Ref / Catalog
1102
Primary DI / UDI-DI
17350081940086
FDA Product Code
KNW
GMDN Term
Mammographic stereotactic biopsy system
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No