FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116020836
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
1000 Micron Single Use HE
Catalog number
HOL1000SHE
Device description
Dornier SingleFlex 1000 High Energy Laser Fiber - Dornier Direct
Published
2019-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121938000MEDILAS H RFID LASER FIBERDornier Medtech America, Inc.2012-08-01GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116020836PackageGS13In Commercial Distribution
00810116020775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116020836008101160208368101160208360810116020836
00810116020775008101160207758101160207750810116020775

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-use, sterileA sterile, surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130789944
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
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06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
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04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
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