Coloplast SUE272

GUDID 05708932688338

SabreLine Single Use Laser Fiber 272um

Coloplast A/S

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 05708932688338
• NIH Device Record Key: 04120458-a82b-4f83-be42-e9f9b66f94f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coloplast
• Version Model Number: SUE272
• Catalog Number: SUE272
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932688321 [Primary]
GS1	05708932688338 [Package]; Contains: 05708932688321; Package: Retail box [3 Units]; In Commercial Distribution

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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• 05708932553773: Restorelle® Y Contour™ Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy with Meridi
• 05708932027953: Irrigation Kit
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• 05708932688543: SabreLine Reusable Laser Fiber 940um
• 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
• 00311701007985: Coloplast® Prep Barrier Film / Coloplast Prep Barrier Film / Prep Prep Barrier Film.
• 00762123049464: Coloplast Fistula and Wound Management System / Coloplast / Coloplast Fistula and wound manag
• 00762123049471: Coloplast Fistula and Wound Management System / Coloplast / Coloplast Free. without filter.
• 00762123049495: Coloplast Fistula and Wound Management System / Coloplast . without filter. 1 Fistula and Woun
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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.
• 00762123049440: Coloplast Fistula Bed Drainage Bag. Bed drainage bag.
• 05708932477956: Coloplast Paste. Fills in cavities/folds. Ostomy Care. 2 oz. / 60 g
• 00762123006894: Coloplast Rings. Pre-cut 50 mm
• 00762123006887: Coloplast Rings. Pre-cut 40 mm
• 00762123006870: Coloplast Rings. Pre-cut 30 mm
• 00762123006863: Coloplast Rings. Pre-cut 25 mm
• 00762123006856: Coloplast Rings. Pre-cut 20 mm
• 00762123006849: Coloplast Rings. Pre-cut 15 mm
• 00762123006832: Coloplast Rings. Pre-cut 10 mm.
• 00762123001493: Coloplast Clamp . For drainable ostomy bags.
• 05708932716482: 13650
• 05708932712408: 13600
• 00762123032299: 21365
• 00762123042977: 00509
• 05708932020190: Coloplast Irrigation Sleeves
• 03600040968116: AE0E38
• 03600040968086: AE0E32
• 03600040926598: AE0D35
• 03600040926574: AE0C35
• 03600040926536: AE0A38
• 03600040926512: AE0A35
• 03600040926482: AE0A32
• 03600040926451: AE0038
• 03600040926413: AE0035
• 03600040926390: AE0032