SEAL RING

GUDID 04953170165856

OLYMPUS MEDICAL SYSTEMS CORP.

Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set Surgical instrument seal/seal maintenance set

Primary Device ID	04953170165856
NIH Device Record Key	18af8f15-7d7d-488e-8ecb-ce9088969675
Commercial Distribution Status	In Commercial Distribution
Brand Name	SEAL RING
Version Model Number	MAJ-1188
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	true
Serial Number	false
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170165856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K002749

FDA Product Code

FDF	Colonoscope and accessories, flexible/rigid