FDA.reportPublic FDA data

ConvertX™ Nephroureteral Stent System

Primary DI
00851571007369
Brand
ConvertX™ Nephroureteral Stent System
Company
BRIGHTWATER MEDICAL, INC.
Model
8.3F - 10.3F Taper x 24cm
Catalog number
100081-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FADStent, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161277000ConvertX Nephroureteral Stent SystemBrightwater Medical2016-11-22FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851571007369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851571007369008515710073698515710073690851571007369

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric ureteral stentA 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
TypeValueUnit
Catheter Gauge8.3French
Catheter Gauge10.3French
Length24Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9512903410xx@xx.xx

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 DIBrandModelCatalogPublished
00851571007208ConvertX™ Nephroureteral Stent System10.3F x 20cm100010-202017-07-07
00851571007222ConvertX™ Nephroureteral Stent System10.3F x 22cm100010-222017-07-07
00851571007246ConvertX™ Nephroureteral Stent System10.3F x 24cm100010-242017-07-07
00851571007260ConvertX™ Nephroureteral Stent System10.3F x 26cm100010-262017-07-07
00851571007284ConvertX™ Nephroureteral Stent System10.3F x 28cm100010-282017-07-07
00851571007345ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 20cm100081-202018-02-06
00851571007352ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 22cm100081-222018-02-06
00851571007376ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 26cm100081-262018-02-06
00851571007383ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 28cm100081-282018-02-06
00851571007482ConvertX™ Nephroureteral Stent System10.3F x 10cm120010-102018-11-08
00851571007499ConvertX™ Nephroureteral Stent System10.3F x 12cm120010-122018-11-08
00851571007505ConvertX™ Nephroureteral Stent System10.3F x 14cm120010-142018-11-08
00851571007512ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 10cm120081-102018-11-08
00851571007529ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 12cm120081-122018-11-08
00851571007536ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 14cm120081-142018-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936534343020Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759149Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759156Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759163Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759170Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759231Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759248Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759255Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759262Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759323Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759330Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759347Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759354Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759415Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759422Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759439Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759446Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759682Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759699Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759705Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759712Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759774Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759781Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759798Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759804Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759866Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759873Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759880Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759897Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759958Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22