ConvertX™ Nephroureteral Stent System

Primary DI
00851571007352
Brand
ConvertX™ Nephroureteral Stent System
Company
BRIGHTWATER MEDICAL, INC.
Model
8.3F - 10.3F Taper x 22cm
Catalog number
100081-22
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
00851571007352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851571007352008515710073528515710073520851571007352

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
Length22Centimeter

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
00851571007369ConvertX™ Nephroureteral Stent System8.3F - 10.3F Taper x 24cm100081-242018-02-06
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
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08714729031802Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729048633Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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