ENDOSCOPE POSITION MARKING PROBE

GUDID 04953170353406

MAJ-1878 SCOPEGUIDE PROBE 2.8MM

OLYMPUS MEDICAL SYSTEMS CORP.

Patient positioning sensor Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal Electromagnetic endoscope tracking system reference transmitter, internal

Primary Device ID	04953170353406
NIH Device Record Key	a2e21c8e-5fa7-4363-94ea-7756fe27e14c
Commercial Distribution Status	In Commercial Distribution
Brand Name	ENDOSCOPE POSITION MARKING PROBE
Version Model Number	MAJ-1878
Company DUNS	711789789
Company Name	OLYMPUS MEDICAL SYSTEMS CORP.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170353406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K134026

FDA Product Code

PGU	Spatial imaging for display of endoscope position