Long Clip

GUDID 04953170200373

OLYMPUS MEDICAL SYSTEMS CORP.

Ligation clip, metallic

• Primary Device ID: 04953170200373
• NIH Device Record Key: 8ef1453a-770d-4263-abdf-814e49533590
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Long Clip
• Version Model Number: HX-610-090L
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 40
• 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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• 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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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170200373 [Primary]
GS1	84953170200379 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183590
• Premarket Notification: K240617

FDA Product Code

• MND: Ligator, esophageal
• PKL: Hemostatic Metal Clip For The Gi Tract

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [Long Clip]

• 04953170209154: HX-610-135L
• 04953170200373: HX-610-090L