allSoft

Primary DI
00812261010939
Brand
allSoft
Company
ALLWIN MEDICAL DEVICES, INC.
Model
allSoft Pediatric Ureteral Stents Open Tip 3F, 16c
Catalog number
POS3-16-G
Device description
allSoft Pediatric Ureteral Stents Open Tip 3F, 16cm with Guidewire
Published
2024-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K190659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190659000Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed TipAllwin Medical Devices, Inc.2019-12-02FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812261010936PackageGS110In Commercial Distribution
00812261010939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081226101093610812261010936
00812261010939008122610109398122610109390812261010939

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.

Contacts#

Phone, Email table
PhoneEmail
714-512-1709info@allwinmedical.com

Regulatory Flags#

DUNS number
796354509
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
00812261016597ASPIASPI Aspiration NeedleASPI22/302024-01-09
00819374021746SURESTRIPSURESTRIP Vitrification StrawSUS-Y2024-01-10
00812261010069allSoftallSoft Ureteral Stent Open TipSOT5/242024-01-09
00812261010823allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 10cPOS3/102024-01-09
00812261010830allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 12cPOS3/122024-01-09
00812261010847allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 14cPOS3/142024-01-09
00812261010854allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 16cPOS3/162024-01-09
00812261010861allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 10cPOS4/102024-01-09
00812261010878allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 12cPOS4/122024-01-09
00812261010885allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 14cPOS4/142024-01-09
00812261010892allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 16cPOS4/162024-01-09
00812261010908allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 10cPOS3/10-G2024-01-09
00812261010915allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 12cPOS3/12-G2024-01-09
00812261010922allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 14cPOS3/14-G2024-01-09
00812261010946allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 10cPOS4/10-G2024-01-09
00812261010953allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 12cPOS4/12-G2024-01-09
00812261010960allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 14cPOS4/14-G2024-01-09
00812261010977allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 16cPOS4/16-G2024-01-09
00812261011806allDrainallDrain Percutaneous Nephrostomy Catheter PigtailPCN-P142024-01-09
00812261011813allSoftallSoft Urinary Diversion Stents [Mono - J] Open TMJO-5/702024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08714729031697Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031703Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031796Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031802Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031819Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031826Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031833Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031840Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729032113Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032120Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032137Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048381Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048398Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048404Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048411Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048428Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729048633Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048640Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048657Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048664Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048671Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24