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SpyGlass M00546160

by Boston Scientific

SpyGlass M00546160 is a Class I device made by Boston Scientific, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729779643), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729779643 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
SpyGlass
Generic name
Medical device integration rack
Model / reference
M00546160
Primary DI / UDI-DI
08714729779643
FDA product code
FFY
GMDN term
Medical device integration rack
Device class
Class I
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)