HD CAMERA HEAD

GUDID 04953170336669

CH-S190-08-LB HD ULTRA-LIGHT URO CAMERA

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera

• Primary Device ID: 04953170336669
• NIH Device Record Key: 3377c17a-a1ae-43c9-8798-1e0bba1a5214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HD CAMERA HEAD
• Version Model Number: OLYMPUS CH-S190-08-LB
• 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	04953170336669 [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

[04953170336669]

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 CAMERA HEAD]

• 04953170336669: CH-S190-08-LB HD ULTRA-LIGHT URO CAMERA
• 04953170268267: "OTV-S7PROH-HD-L08E HD URO CAMERA"