FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116022045
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
Dual Flex with Hydrophilic Tip, Angle, Super Stiff
Catalog number
MERI3815AS
Device description
"PTFE/Nitinol Guide Wire 0.038"", 150cm, Angle 3cm tip, flexible both ends, Super Stiff"
Published
2020-02-18
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
EYAStylet, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYAStylet, UreteralGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116022052PackageGS15In Commercial Distribution
00810116022045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116022052008101160220528101160220520810116022052
00810116022045008101160220458101160220450810116022045

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Regulatory Flags#

DUNS number
130789944
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810116024056Dornier MedTech AXIS II Clerix Suction URS Reverse DeflectionAX204182026-03-26
00810116024070Dornier MedTech AXIS II Clerix Suction URSAX204192026-03-26
00810116024094Dornier MedTech AXIS II Clerix Suction URSAX204202026-03-26
00810116024117Dornier MedTech AXIS II Clerix Suction URSAX204212026-03-26
00810116024049Dornier MedTech AXIS II Portable MonitorAX201002026-03-24
00810116023769Dornier HOOVER Access SheathIVX-NB-150IVX-NB-1502026-01-14
00810116023370Dornier MedTech Axis II Video ProcessorAX204072026-01-22
00810116023417Dornier MedTechDornier AXIS II D URS FLEX US - UreteroscopeAX204142026-01-22
00810116023431Dornier MedTechDornier AXIS II CYSTO FLEX US - UreteroscopeAX204112026-01-22
00810116023523Axis IIDornier AXIS II E URS FLEX US - UreteroscopeAX204092026-01-22
00810116023585Dornier MedTechAXIS II URS SLIM 7.5 FLEX SU USAX204172026-01-22
00810116023608Dornier HOOVER Access SheathIVX-NS-1040IVX-NS-10402026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925003446GYRUS ACMI, INCGyrus ACMI, LLCEYA2024-07-24
G586UR96286210Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
G586UR96286410Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
00842962125588HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125595HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125601HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125618HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125625HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125632HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125649HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125656HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125670HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125687HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125694HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125700HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125717HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125724HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125731HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125748HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125755HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125762HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125809HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125816HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125823HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842331134531Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
00842331135897Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
00816349011733ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011740ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011757ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011764ZIPwire™Lake Region MedicalEYA2020-06-30