Single Use Electrosurgical Snare SD-400

GUDID 14953170396691

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 14953170396691
• NIH Device Record Key: d369f6a4-adf6-4569-8d12-f8ec3e44a60d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Electrosurgical Snare SD-400
• Version Model Number: SD-400-10
• 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
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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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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170396694 [Primary]
GS1	14953170396691 [Package]; Contains: 04953170396694; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172734

FDA Product Code

• FGX: SNARE, NON-ELECTRICAL

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: 2017-12-13

On-Brand Devices [Single Use Electrosurgical Snare SD-400]

• 14953170396714: SD-400-15
• 14953170396691: SD-400-10
• 14953170408257: SD-400U-15
• 14953170408240: SD-400U-10