Vortek BCFD65
GUDID 05701780338776
Coloplast A/S
Urological surgical procedure kit, non-medicated, single-use| Primary Device ID | 05701780338776 |
| NIH Device Record Key | d171ef0d-9110-45ef-a1b1-812a6a484453 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vortek |
| Version Model Number | BCFD65 |
| Catalog Number | BCFD65 |
| 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 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com |
Device Dimensions
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
| Length | 28 Centimeter |
| Catheter Gauge | 6 French |
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 | 05701780338752 [Primary] |
| GS1 | 05701780338769 [Package] Contains: 05701780338752 Package: Retail Box [1 Units] In Commercial Distribution |
| GS1 | 05701780338776 [Package] Contains: 05701780338769 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 |
Trademark Results [Vortek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VORTEK 98104299 not registered Live/Pending |
Accutrol, LLC 2023-07-27 |
 VORTEK 90715814 not registered Live/Pending |
Suplee Hollow Machine, LLC 2021-05-17 |
 VORTEK 88267803 not registered Live/Pending |
Ideal Outdoors LLC 2019-01-18 |
 VORTEK 87486324 not registered Dead/Abandoned |
GSG Holdings, Inc. 2017-06-13 |
 VORTEK 87347378 5556526 Live/Registered |
WILD SALES, LLC 2017-02-23 |
 VORTEK 86316924 not registered Dead/Abandoned |
Adaptive Engineering Lab, Inc. 2014-06-23 |
 VORTEK 86170596 not registered Dead/Abandoned |
Famma Group, Inc. 2014-01-21 |
 VORTEK 85873560 4566336 Live/Registered |
VORTEK PRODUCTS, INC. 2013-03-12 |
 VORTEK 79313488 not registered Live/Pending |
W.F. S.R.L. 2021-04-15 |
 VORTEK 78165873 2833249 Live/Registered |
Hoffend & Sons, Inc. 2002-09-19 |
 VORTEK 76474477 3033398 Dead/Cancelled |
Global VR, Inc. 2002-12-11 |
 VORTEK 75617069 not registered Dead/Abandoned |
Vortek Products, Inc 1999-01-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.