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PrimeSight 02-4318

by SCHÖLLY FIBEROPTIC GmbH

PrimeSight 02-4318 is a Class II device made by SCHÖLLY FIBEROPTIC GmbH, listed in FDA GUDID since 10 Nov 2016 (UDI-DI 04250480106358), 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 Number04250480106358 UDI-DI Date10 Nov 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  • Withdrawn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
PrimeSight
Generic name
Rigid optical sinoscope
Model / reference
02-4318
Primary DI / UDI-DI
04250480106358
FDA product code
EOB
GMDN term
Rigid optical sinoscope
Device class
Class II
Regulation number
874.4760
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Rigid optical sinoscope

Similar devices

Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Other devices from SCHÖLLY FIBEROPTIC GmbH

  • PE591A

    Class IIa

  • SmartVue®

    Class I

  • 41.0600d

    Class I

  • 11-0441-A

    Class IIa

See all devices from SCHÖLLY FIBEROPTIC GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)