FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116021697
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
Bipolar Needle 24 Fr. Electrode-Sterile, Single-Us
Catalog number
BIPNEEL
Device description
Bipolar Needle 24 Fr. Electrode-Sterile, Single-Use. (6/box)
Published
2020-06-19
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
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116021765PackageGS16In Commercial Distribution
00810116021697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116021765008101160217658101160217650810116021765
00810116021697008101160216978101160216970810116021697

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Regulatory Flags#

DUNS number
130789944
Device count
1
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

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Primary DI, Brand, Company table
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10801334000707Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FAS2017-05-03
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