FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116023943
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
Dornier Falcon
Catalog number
IVX-GF1-1808A
Device description
Falcon Single Use Grasping Forceps
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116023950PackageGS15In Commercial Distribution
10810116023940PackageGS140In Commercial Distribution
00810116023943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116023950008101160239508101160239500810116023950
1081011602394010810116023940
00810116023943008101160239438101160239430810116023943

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic stone-retrieval forceps, single-useA flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. 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
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
00810116023615Dornier HOOVER Access SheathIVX-NS-1050IVX-NS-10502026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029872ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029889ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029919ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029933ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029940ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029957ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029964ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029971ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029988ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029995ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030007ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030014ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030021ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030038ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030045ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030052ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030069ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030076ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030083ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030090ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030106ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030113ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030120ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030137ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030144ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18