Single Use Electrosurgical Knife KD-650 N3498840

GUDID 14953170453981

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 14953170453981
• NIH Device Record Key: ac49fa83-f9d4-44c6-b775-c344fb12c57f
• Commercial Distribution Discontinuation: 2023-05-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Single Use Electrosurgical Knife KD-650
• Version Model Number: KD-650Q
• Catalog Number: N3498840
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• 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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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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
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• 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	04953170453984 [Primary]
GS1	14953170453981 [Package]; Contains: 04953170453984; Package: [1 Units]; Discontinued: 2023-05-08; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092309

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

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

[14953170453981]

Ethylene Oxide

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

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[14953170453981]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-29

On-Brand Devices [Single Use Electrosurgical Knife KD-650]

• 14953170265782: KD-650U
• 14953170265775: KD-650Q
• 14953170265768: Single Use Electrosurgical Knife KD-650
• 14953170453998: KD-650U
• 14953170453981: KD-650Q
• 14953170453974: KD-650L