FDA.reportPublic FDA data

allSoft

Primary DI
00812261010885
Brand
allSoft
Company
ALLWIN MEDICAL DEVICES, INC.
Model
allSoft Pediatric Ureteral Stents Open Tip 4F, 14c
Catalog number
POS4/14
Device description
allSoft Pediatric Ureteral Stents Open Tip 4F, 14cm
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

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
10812261010882PackageGS110In Commercial Distribution
00812261010885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081226101088210812261010882
00812261010885008122610108858122610108850812261010885

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.

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
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
00812261010939allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 16cPOS3-16-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
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