HALOGEN LIGHT SOURCE

GUDID 04953170024528

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic light source, line-powered

• Primary Device ID: 04953170024528
• NIH Device Record Key: acb8cd0f-2e04-42d9-9062-d07db15a3e5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALOGEN LIGHT SOURCE
• Version Model Number: OLYMPUS CLK-4
• 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
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• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170024528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993041

FDA Product Code

• KGE: FORCEPS, BIOPSY, ELECTRIC

Sterilization

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

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 [HALOGEN LIGHT SOURCE]

• 04953170024528: OLYMPUS CLK-4
• 04953170024511: CLK-4 120V SIMPLIFIED LIGHT SOURCE
• 04953170024481: CLH-SC
• 04953170024474: CLH-SC
• 04953170024467: CLH-SC 150W HALOGEN LIGHT SOUR CE
• 04953170024429: CLH-250
• 04953170024412: CLH-250W HALOGEN LIGHT SOURCE