FDA.reportPublic FDA data

OCTAX Laser Shot

Primary DI
04260502101483
Brand
OCTAX Laser Shot
Company
Octax Microscience GmbH
Model
19310/0148
Catalog number
19310/0148
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MRXSystem, Assisted Reproduction Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRXSystem, Assisted Reproduction LaserObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260502101483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260502101483042605021014834260502101483

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction laser systemA portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314169074
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260604170011Octax LaserShot M19310/0148M19310/0148M2020-05-11
04260604170028Octax NaviLase19310/014619310/01462020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858604006054LYKOS DTSHAMILTON THORNE, INC.MRX2023-06-07
04260604170011Octax LaserShot MOctax Microscience GmbHMRX2020-05-11
04260604170028Octax NaviLaseOctax Microscience GmbHMRX2020-05-11
00858604006276ZILOS-tk™HAMILTON THORNE, INC.MRX2019-11-30
00858604006290LYKOS™HAMILTON THORNE, INC.MRX2019-11-30
05060488042393Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042409Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042669Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042676Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042683Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042690Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042706Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042713Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042720Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042737Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042744Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042751Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042768Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042812Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043277Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043338Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043406Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043628Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043635Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043772Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043789Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044816Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044823Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044830Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044847Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23