REFERENCE PLATE

GUDID 04953170305672

MAJ-1860 ScopeGuide Reference Plate

OLYMPUS MEDICAL SYSTEMS CORP.

Gastrointestinal catheter/endoscope tracking system

• Primary Device ID: 04953170305672
• NIH Device Record Key: e14ee8a3-df5c-451f-abd9-77027373759a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFERENCE PLATE
• Version Model Number: MAJ-1860
• 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
• 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
• 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	04953170305672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103312

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

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[04953170305672]

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[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

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[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

[04953170305672]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

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• 14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip: 2024-09-17
• 14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip: 2024-09-17
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