Vortek ACA206

GUDID 03600040910894

Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stiff.

Coloplast A/S

Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent

• Primary Device ID: 03600040910894
• NIH Device Record Key: 4ff50be7-f6bc-4019-bde9-a7b58cdeb338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vortek
• Version Model Number: ACA206
• Catalog Number: ACA206
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03600040910894 [Package]; Contains: 03600040910955; Package: Shipper Box [24 Units]; In Commercial Distribution
GS1	03600040910931 [Primary]
GS1	03600040910955 [Package]; Contains: 03600040910931; Package: Retail Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201436

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: 2021-12-27
• Device Publish Date: 2021-12-17

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