SureBlade

GUDID 00850013050147

SureBlade 8mm, BiFacet, single edged, (No.11)

Clinicon Corporation

General/multiple surgical diode/carbon dioxide laser system

• Primary Device ID: 00850013050147
• NIH Device Record Key: 4426407b-4b53-448c-886c-3046534b0612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureBlade
• Version Model Number: 2986
• Company DUNS: 785275777
• Company Name: Clinicon Corporation
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013050147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983463

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

[00850013050147]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-13
• Device Publish Date: 2021-05-05

On-Brand Devices [SureBlade]

• 00850013050147: SureBlade 8mm, BiFacet, single edged, (No.11)
• 00850013050130: SureBlade 6mm, Lance, double edged, (No. 13)