ConvertX™ Nephroureteral Stent System 120081-10
GUDID 00851571007512
BRIGHTWATER MEDICAL, INC.
Polymeric ureteral stent| Primary Device ID | 00851571007512 |
| NIH Device Record Key | c6e31b5e-00df-4f53-964b-ee838389d7da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ConvertX™ Nephroureteral Stent System |
| Version Model Number | 8.3F - 10.3F Taper x 10cm |
| Catalog Number | 120081-10 |
| 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 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| Phone | 9512903410 |
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| 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 |
Device Dimensions
| Catheter Gauge | 8.3 French |
| Catheter Gauge | 8.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
| Length | 10 Centimeter |
| Catheter Gauge | 10.3 French |
| Catheter Gauge | 8.3 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851571007512 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-10 |
| Device Publish Date | 2018-11-08 |
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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