HD AUTOCLAVABLE CAMERA HEAD

GUDID 04953170228834

"OTV-S7PROH-HD-12E CAM HEAD 1.2X EYEPIECE"

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera

• Primary Device ID: 04953170228834
• NIH Device Record Key: 95fde058-021c-4253-9a05-5e9fc4d2319a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Version Model Number: OTV-S7ProH-HD-12E
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170228834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955404

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04953170228834]

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

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"