Vortek ACB174

GUDID 05701780332422

Coloplast A/S

Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use

• Primary Device ID: 05701780332422
• NIH Device Record Key: 9c25ea32-790f-4755-bcc3-3a4988be7552
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vortek
• Version Model Number: ACB174
• Catalog Number: ACB174
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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)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
• 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

• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter
• Catheter Gauge: 7 French
• Length: 26 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05701780332415 [Primary]
GS1	05701780332422 [Package]; Contains: 05701780332415; Package: Retail Box [1 Units]; In Commercial Distribution
GS1	05701780332446 [Package]; Package: Shipper Box [34 Units]; In Commercial Distribution

FDA Product Code

• FAD: Stent, ureteral

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: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [Vortek]

• 03600040910764: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910924: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910788: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910894: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910740: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910856: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910795: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910726: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 03600040910979: Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stif
• 05701780338974: BCFD77
• 05701780338943: BCFD76
• 05701780338912: BCFD75
• 05701780338899: BCFD74
• 05701780338851: BCFD73
• 05701780338820: BCFD67
• 05701780338790: BCFD66
• 05701780338776: BCFD65
• 05701780338738: BCFD64
• 05701780338707: BCFD63
• 05701780338677: BCFD57
• 05701780338653: BCFD55
• 05701780338622: BCFD54
• 05701780338585: BCFD53
• 05701780338561: BCFD47
• 05701780338530: BCFD45
• 05701780338509: BCFD44
• 05701780338479: BCFD43
• 05701780338431: BCFA77
• 05701780338417: BCFA76
• 05701780338387: BCFA75
• 05701780338356: BCFA74
• 05701780338318: BCFA73
• 05701780338288: BCFA67
• 05701780338257: BCFA66
• 05701780338233: BCFA65
• 05701780338196: BCFA64
• 05701780338165: BCFA63
• 05701780338134: BCFA57
• 05701780338103: BCFA55
• 05701780338080: BCFA54
• 05701780338059: BCFA53
• 05701780338028: BCFA47
• 05701780337984: BCFA45
• 05701780337953: BCFA44
• 05701780337939: BCFA43
• 05701780333757: ACBM86
• 05701780333719: ACBM85
• 05701780333696: ACBM84
• 05701780333658: ACBM83
• 05701780333627: ACBM77