HD AUTOCLAVABLE CAMERA HEAD

GUDID 04953170310782

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 04953170310782
• NIH Device Record Key: 715d8e14-26e0-419b-a546-348d815a373b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Version Model Number: OLYMPUS CH-S190-XZ-Q
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170310782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102059

FDA Product Code

• NWB: Endoscope, accessories, narrow band spectrum

Sterilization

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

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

[04953170310782]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [HD AUTOCLAVABLE CAMERA HEAD]

• 04953170310782: OLYMPUS CH-S190-XZ-Q
• 04953170252945: OTV-S7ProH-HD-10Q
• 04953170252914: "OTV-S7PROH-HD-10E CAM HEAD 1.0X EYEPIECE"
• 04953170228865: OTV-S7ProH-HD-12Q
• 04953170228834: "OTV-S7PROH-HD-12E CAM HEAD 1.2X EYEPIECE"