Dornier MedTech

Primary DI
04049958002151
Brand
Dornier MedTech
Company
Dornier MedTech Laser GmbH
Model
600 Micron Disposable
Catalog number
K2011824
Device description
600 Micron Disposable Diode Laser Lightguide, 2.5 meter length, 1.07 mm outer diameter
Published
2018-09-11
Public version status
New
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
K991183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991183000DORNIER LASERTRODE FIBERDornier Surgical Products, Inc.1999-06-09GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049958002151PackageGS110In Commercial Distribution
04049958002144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049958002151040499580021514049958002151
04049958002144040499580021444049958002144

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
389567538
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
true
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
04049958000096Dornier MedTech600 Micron Disposable BarefiberK10105002018-09-12
04049958002137Dornier MedTech400 Micron Disposable NA 0.37K20118222018-09-13
04049958000072Dornier MedTech600 Micron Disposable K10080842018-09-11
04049958000058Dornier MedTech600 Micron Disposable Nozzle TipK10012912018-09-11
04049958000614Dornier MedTech600 Micron Disposable Nozzle TipK10012922018-09-11
04049958000621Dornier MedTech600 Micron Disposable Nozzle TipK10012932018-09-11
04049958001130Dornier MedTech400 Micron Disposable NA 0.37K20107102018-09-11
04049958001444Dornier MedTech600 Micron Disposable K20121462018-09-11

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