VIDEO SYSTEM

GUDID 04953170136917

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 04953170136917
• NIH Device Record Key: e1645947-d611-40bb-afd5-22589cb60951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDEO SYSTEM
• Version Model Number: OTV-SC
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170136917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002231
• Premarket Notification: K955404

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid
• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

[04953170136917]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

On-Brand Devices [VIDEO SYSTEM]

• 04953170170461: "OTV-SI(B) OTV-SI OFFICE VID SYSTM W/PUMP"
• 04953170169892: OTV-SI
• 04953170169885: "OTV-SI(A) OTV-SI OFFICE VID SYS W/O PUMP"
• 04953170136917: OTV-SC
• 04953170136894: "OTV-SC Office Video Processor"