Coloplast RUS365

GUDID 05708932688482

SabreLine Reusable Laser Fiber 365um

Coloplast A/S

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 05708932688482
• NIH Device Record Key: 64224df2-c270-418b-9d21-4d367cff969c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coloplast
• Version Model Number: RUS365
• Catalog Number: RUS365
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)258-3476
• Email: urology@coloplast.com

Device Dimensions

• Outer Diameter: 365 Micrometer

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932688482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182831

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-11
• Device Publish Date: 2019-10-03

On-Brand Devices [Coloplast]

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• 05708932688512: SabreLine Reusable Laser Fiber 550um
• 05708932688482: SabreLine Reusable Laser Fiber 365um
• 05708932688451: SabreLine Reusable Laser Fiber 272um
• 05708932688420: SabreLine Single Use Laser Fiber 940um
• 05708932688390: SabreLine Single Use Laser Fiber 550um
• 05708932688369: SabreLine Single Use Laser Fiber 365um
• 05708932688338: SabreLine Single Use Laser Fiber 272um
• 05708932688307: SabreLine Single Use Laser Fiber 250um
• 05708932688277: SabreGuard Single Use Laser Fiber 250um
• 05708932687058: SabreGuard Single Use Laser Fiber 150um
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• 00762123049587: Coloplast Flexible lid / Coloplast / Coloplast Fistula Flexible Lid. without filter. The man
• 00762123051009: Coloplast Flexible lid / Coloplast . without filter. Mini. Fistula and Wound Manager Size Mini
• 00762123049518: Coloplast / Coloplast Drain Port.
• 00762123051085: Coloplast Fistula Bed Drainage Bag. Bed drainage bag.
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• 05708932712408: 13600
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• 00762123042977: 00509
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• 03600040968116: AE0E38
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• 03600040926482: AE0A32
• 03600040926451: AE0038
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• 03600040926390: AE0032