OES HYSTEROFIBERSCOPE

GUDID 04953170051128

HYF-1T HYS-Fiberscope 4.9mm dia w/chan

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope

Primary Device ID	04953170051128
NIH Device Record Key	71b3122c-2052-4b03-a01c-dae63601c1ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	OES HYSTEROFIBERSCOPE
Version Model Number	OLYMPUS HYF TYPE 1T
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170051128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K891451

FDA Product Code

HIH	HYSTEROSCOPE (AND ACCESSORIES)