12G-SDI cable N6013400

GUDID 04953170415623

OLYMPUS MEDICAL SYSTEMS CORP.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 04953170415623
• NIH Device Record Key: ab42ff48-a2d3-46e7-93f7-6bacc7ebac38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12G-SDI cable
• Version Model Number: MAJ-2428
• Catalog Number: N6013400
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170415623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222584

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)
• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-12
• Device Publish Date: 2023-07-04

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• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17
• 04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip: 2024-09-17
• 14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip: 2024-09-17
• 14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip: 2024-09-17
• 14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 14953170409971 - Single Use Aspiration Needle NA-U401SX: 2024-07-11