Carl Zeiss Meditec AG

Address:Goeschwitzer Strasse 51-52,JENA Thuringia,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Management, Ophthalmic (NFJ) (3) Drape, Surgical, Exempt (PUI) (2) Microscope, Surgical, General & Plastic Surgery (FSO) (1) System, X-Ray, Angiographic (IZI) (1) Unit, Phacofragmentation (HQC) (1)

Premarket Exempt

No Yes

Clear

BLUE 400 - 04049539104342 Catalog Number :

Device Description : for OPMI PENTERO 800 and OPMI PENTERO 900

Device Class : 1

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

YELLOW 560 - 04049539104359 Catalog Number :

Device Description : for OPMI PENTERO 800 and OPMI PENTERO 900

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : IZI

Prescription Use : Yes

Device Count : 1

CALLISTO eye - 04049539104366 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : NFJ

Prescription Use : Yes

Device Count : 1

CALLISTO eye - 04049539104403 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : NFJ

Prescription Use : Yes

Device Count : 1

CALLISTO eye - 04049539104410 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : NFJ

Prescription Use : Yes

Device Count : 1

QUATTRO CASSETTE - 04049539104526 Catalog Number :

Device Description : The Product is a single use sterile accessory kit for the ZEISS phaco and vitreo The Product is a single use sterile accessory kit for the ZEISS phaco and vitreoretinal systems and has been designed to direct balanced salt solution from irrigation source to the surgical handpieces and to convey the materials removed from the eye to a reservoir during eye surgery on anterior and posterior segments of the human eye.

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 1

SCREEN COVER QUATERA 700 - 04049539104700 Catalog Number :

Device Description : The products are single use, sterile drapes to cover all surfaces of the main de The products are single use, sterile drapes to cover all surfaces of the main device with a potential need to get in contact with sterile objects during surgical procedures.

Device Class : 2

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

TRAY COVER QUATERA 700 - 04049539104731 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

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