FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116021581
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
Dornier Magellan Ureteral Access Sheath, 10/12Fr x
Catalog number
MAG10225
Device description
Dornier Magellan Ureteral Access Sheath, 10/12Fr x 25cm
Published
2023-07-27
Public version status
Update
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201815000Dornier MAGELLAN Ureteral Access SheathDornier Medtech America, Inc.2020-11-20FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116021581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116021581008101160215818101160215810810116021581

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral sheathA flexible tube intended to be used for ureteral access for the passage of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130789944
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
00810116024056Dornier MedTechAXIS II Clerix Suction URS Reverse DeflectionAX204182026-03-26
00810116024070Dornier MedTechAXIS II Clerix Suction URSAX204192026-03-26
00810116024094Dornier MedTechAXIS II Clerix Suction URSAX204202026-03-26
00810116024117Dornier MedTechAXIS II Clerix Suction URSAX204212026-03-26
00810116023776Dornier MedTechBIPOLAR 12 Degree Medium Cutting Loop ElectrodeBIP12CLM2026-10-05
00810116023790Dornier MedTechBIPOLAR 12 Degree Large Cutting Loop ElectrodeBIP12CLL2026-10-05
00810116023806Dornier MedTechBIPOLAR 30 Degree Medium Cutting Loop ElectrodeBIP30CLM2026-10-05
00810116023813Dornier MedTechBIPOLAR 30 Degree Large Cutting Loop ElectrodeBIP30CLL2026-10-05
00810116023851Dornier MedTechBIPOLAR Medium Bladder Loop ElectrodeBIP12CLL2026-10-05
00810116023875Dornier MedTechBIPOLAR Needle ElectrodeBIPNEEL2026-10-05
00810116023899Dornier MedTechBIPOLAR Dornier Plasma Disc ElectrodeBIPDDSC2026-10-05
00810116023387Dornier Axis IIDornier AXIS II E URS FLEX EU - UreteroscopeAX204082026-05-06
00810116023400Dornier MedTechDornier AXIS II D URS FLEX EU - UreteroscopeAX204132026-05-06
00810116023424Dornier MedTechDornier AXIS II CYSTO FLEX EU - UreteroscopeAX204102026-05-06
00810116023578Dornier MedTechDornier AXIS II Slim URS FLEX EU - UreteroscopeAX204162026-05-06
00810116023721Dornier MedTech Dornier Vesta Nitinol ExtractorIVX-US-F11102026-04-21
00810116023738Dornier MedTech Dornier Ceres Nitinol ExtractorIVX-US-T08102026-04-21
00810116023745Dornier MedTech Dornier Ceres Nitinol ExtractorIVX-US-T11102026-04-21
00810116023943Dornier MedTech Dornier FalconIVX-GF1-1808A2026-04-17
00810116024049Dornier MedTech AXIS II Portable MonitorAX201002026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013645120Prodeon Urethral Sheath SystemProdeon Medical, Inc.FED2026-10-07
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
06942804744602Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744619Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744626Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744633Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744640Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744657Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744664Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744671Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744688Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744695Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744701Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744718Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744725Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744732Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744749Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744756Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744763Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744770Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744787Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744794Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22