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

Drape, Surgical (KKX) (7) Apparatus, Cautery, Radiofrequency, Ac-Powered (HQR) (2) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

No Yes

Clear

DIATHERMY BIPOLAR CABLE - 04049539100498 Catalog Number :

Device Description : This re-usable device is an accessory for ZEISS phaco systems. It has been desig This re-usable device is an accessory for ZEISS phaco systems. It has been designed to connect the diathermy handpieces to the main device during human eye surgery.

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : HQR

Prescription Use : Yes

Device Count : 1

DIATHERMY FORCEPS - 04049539100504 Catalog Number :

Device Description : This active re-usable device is an accessory for ZEISS phaco systems. It has bee This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.

Device Class : 2

Duns Number: 342228620

Premarket Exempt : No

Product Code : HQR

Prescription Use : Yes

Device Count : 1

STERILISATION TRAY - 04049539100610 Catalog Number :

Device Description : This re-usable device is an accessory for ZEISS phaco systems. It is used to sto This re-usable device is an accessory for ZEISS phaco systems. It is used to store medical accessories during steam sterilization to ensure that reproducible sterilization results are obtained.

Device Class : 1

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

INTRABEAM® Drape - 04049539101150 Catalog Number :

Device Class :

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

DRAPES sterile - 04049539101167 Catalog Number :

Device Class :

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

OPMI® Drapes - 04049539101174 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

OPMI® Drapes sterile - 04049539101181 Catalog Number :

Device Class :

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

OPMI® Drapes sterile - 04049539101198 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

OPMI® Drapes sterile - 04049539101204 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

OPMI® Drapes sterile - 04049539101211 Catalog Number :

Device Class : 2

Duns Number: 342228620

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

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