VIDEO SYSTEM

GUDID 04953170136894

"OTV-SC Office Video Processor"

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic video image processing unit

• Primary Device ID: 04953170136894
• NIH Device Record Key: c9677f58-4783-476d-bf39-122dbe0d6894
• 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
• 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	04953170136894 [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

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

[04953170136894]

Ethylene Oxide;High-level Disinfectant

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"