Home GUDID 00851571007376
ConvertX™ Nephroureteral Stent System
Primary DI 00851571007376
Brand ConvertX™ Nephroureteral Stent System
Company BRIGHTWATER MEDICAL, INC.
Model 8.3F - 10.3F Taper x 26cm
Catalog number 100081-26
Published 2018-02-06
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name FAD Stent, Ureteral
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAD Stent, Ureteral Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851571007376 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851571007376 00851571007376 851571007376 0851571007376
GMDN Terms# Term, Definition table Term Definition Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 8.3 French Catheter Gauge 10.3 French Length 26 Centimeter
Regulatory Flags# DUNS number 080049659 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00851571007208 ConvertX™ Nephroureteral Stent System 10.3F x 20cm 100010-20 2017-07-07 00851571007222 ConvertX™ Nephroureteral Stent System 10.3F x 22cm 100010-22 2017-07-07 00851571007246 ConvertX™ Nephroureteral Stent System 10.3F x 24cm 100010-24 2017-07-07 00851571007260 ConvertX™ Nephroureteral Stent System 10.3F x 26cm 100010-26 2017-07-07 00851571007284 ConvertX™ Nephroureteral Stent System 10.3F x 28cm 100010-28 2017-07-07 00851571007345 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 20cm 100081-20 2018-02-06 00851571007352 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 22cm 100081-22 2018-02-06 00851571007369 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 24cm 100081-24 2018-02-06 00851571007383 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 28cm 100081-28 2018-02-06 00851571007482 ConvertX™ Nephroureteral Stent System 10.3F x 10cm 120010-10 2018-11-08 00851571007499 ConvertX™ Nephroureteral Stent System 10.3F x 12cm 120010-12 2018-11-08 00851571007505 ConvertX™ Nephroureteral Stent System 10.3F x 14cm 120010-14 2018-11-08 00851571007512 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 10cm 120081-10 2018-11-08 00851571007529 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 12cm 120081-12 2018-11-08 00851571007536 ConvertX™ Nephroureteral Stent System 8.3F - 10.3F Taper x 14cm 120081-14 2018-11-08
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