ConvertX™ Nephroureteral Stent System 100081-22
GUDID 00851571007352
BRIGHTWATER MEDICAL, INC.
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 | 00851571007352 |
| NIH Device Record Key | 65607dc8-475b-4d4f-bbe0-0a9eba6e384f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ConvertX™ Nephroureteral Stent System |
| Version Model Number | 8.3F - 10.3F Taper x 22cm |
| Catalog Number | 100081-22 |
| Company DUNS | 080049659 |
| Company Name | BRIGHTWATER MEDICAL, INC. |
| 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 | true |
| 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 | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx | |
| Phone | 9512903410 |
| xx@xx.xx |
Device Dimensions
| Length | 22 Centimeter |
| Length | 22 Centimeter |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 22 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851571007352 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161277
FDA Product Code
| FAD | Stent, Ureteral |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-10 |
| Device Publish Date | 2018-02-06 |
On-Brand Devices [ConvertX™ Nephroureteral Stent System]
| 00851571007383 | 8.3F - 10.3F Taper x 28cm |
| 00851571007376 | 8.3F - 10.3F Taper x 26cm |
| 00851571007369 | 8.3F - 10.3F Taper x 24cm |
| 00851571007352 | 8.3F - 10.3F Taper x 22cm |
| 00851571007345 | 8.3F - 10.3F Taper x 20cm |
| 00851571007284 | 10.3F x 28cm |
| 00851571007260 | 10.3F x 26cm |
| 00851571007246 | 10.3F x 24cm |
| 00851571007222 | 10.3F x 22cm |
| 00851571007208 | 10.3F x 20cm |
| 00851571007536 | 8.3F - 10.3F Taper x 14cm |
| 00851571007529 | 8.3F - 10.3F Taper x 12cm |
| 00851571007512 | 8.3F - 10.3F Taper x 10cm |
| 00851571007505 | 10.3F x 14cm |
| 00851571007499 | 10.3F x 12cm |
| 00851571007482 | 10.3F x 10cm |
Trademark Results [ConvertX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONVERTX 86534783 5601549 Live/Registered |
BrightWater Medical, Inc. 2015-02-13 |
 CONVERTX 78267482 2926982 Dead/Cancelled |
Shinano Kenshi Kabushiki Kaisha 2003-06-26 |
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