SIE AG, Surgical Instrument Engineering

Address:Allmendstrasse 11,PORT Bern,CH

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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

Laser, Ophthalmic (HQF) (5) Ophthalmic Femtosecond Laser (OOE) (5)

Premarket Exempt

Clear

FEMTO LDVᵀᴹ Intershields - 07640167750818 Catalog Number : 510.710.317

Device Description : Intershield d330 for LCS

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 10

FEMTO LDVᵀᴹ Intershields - 07640167750825 Catalog Number : 510.710.314

Device Description : Intershield d360 for LCS

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 10

FEMTO LDVᵀᴹ Intershields - 07640167750832 Catalog Number : 510.710.311

Device Description : Intershield d390 for LCS

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 10

FEMTO LDVᵀᴹ Intershields - 07640167750849 Catalog Number : 510.710.308

Device Description : Intershield d420 for LCS

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 10

FEMTO LDVᵀᴹ Intershields - 07640167750856 Catalog Number : 510.710.305

Device Description : Intershield d450 for LCS

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 10

Procedure Pack Z8 - 07640167751334 Catalog Number : 510.700.119

Device Description : Procedure Pack for Cataract Surgery SLIM

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

Procedure Pack Z8 - 07640167751341 Catalog Number : 510.700.120

Device Description : Procedure Pack Corneal Surgery 8.5 SLIM

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

Procedure Pack Z8 - 07640167751358 Catalog Number : 510.700.121

Device Description : Procedure Pack Corneal Surgery 9.0 SLIM

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

Procedure Pack Z8 - 07640167751365 Catalog Number : 510.700.122

Device Description : Procedure Pack Corneal Surgery 9.5 SLIM

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

Procedure Pack Z8 - 07640167751372 Catalog Number : 510.700.123

Device Description : Procedure Pack Corneal Surgery 10.0 SLIM

Device Class :

Duns Number: 482163628

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

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