ConvertX™ Nephroureteral Stent System 120010-10

GUDID 00851571007482

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: 00851571007482
• NIH Device Record Key: 35425ddb-8b4a-48b4-a652-bd436fa33a56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConvertX™ Nephroureteral Stent System
• Version Model Number: 10.3F x 10cm
• Catalog Number: 120010-10
• 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
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx
• Phone: 9512903410
• Email: xx@xx.xx

Device Dimensions

• Catheter Gauge: 10.3 French
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French
• Length: 10 Centimeter
• Catheter Gauge: 10.3 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851571007482 [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