Single Use Electrosurgical Knife KD-655

GUDID 14953170405621

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 14953170405621
• NIH Device Record Key: a427b291-916e-4b90-8d98-157c2ef329b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Electrosurgical Knife KD-655
• Version Model Number: KD-655L
• 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: 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	04953170405624 [Primary]
GS1	14953170405621 [Package]; Contains: 04953170405624; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171158

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-12-19

On-Brand Devices [Single Use Electrosurgical Knife KD-655]

• 14953170405645: KD-655U
• 14953170405638: KD-655Q
• 14953170405621: KD-655L
• 14953170377539: KD-655U
• 14953170377515: KD-655Q
• 14953170377485: KD-655L