SureGuide

GUDID 00850013050161

SureGuide, 2.00m Fiber Cable Assembly, ST Connector

Clinicon Corporation

General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 00850013050161
• NIH Device Record Key: 8a520048-6189-4642-9821-224432b60c5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureGuide
• Version Model Number: 4140
• 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	00850013050161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992472

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

[00850013050161]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-14
• Device Publish Date: 2021-05-06

On-Brand Devices [SureGuide]

• 00850013050185: SureGuide, 2.75m Fiber Cable Assembly, ST Connector
• 00850013050178: SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire
• 00850013050161: SureGuide, 2.00m Fiber Cable Assembly, ST Connector
• 00850013050154: SureGuide, 2.00m Fiber Cable Assembly, SMA Connector with Interlock Wire