FDA.reportPublic FDA data

R+

Primary DI
00812261011905
Brand
R+
Company
ALLWIN MEDICAL DEVICES, INC.
Model
R+ Urinary Diversion Stents [Mono - J] Open Tip 6F
Catalog number
MJO-6/70-R+
Device description
R+ Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm
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
10812261011902PackageGS110In Commercial Distribution
00812261011905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081226101190210812261011902
00812261011905008122610119058122610119050812261011905

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
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

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