Gyroscope Usa, Inc.

Address:2200 Renaissance Boulevard,King of Prussia,PA,19406,US

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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

Cannula, Ophthalmic (HMX) (6) Syringe, Piston (FMF) (6)

Premarket Exempt

Clear

Orbit Subretinal Delivery System - 00850009362001 Catalog Number :

Device Description : Subretinal Injection Device Set

Device Class :

Duns Number: 071418804

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00850009362018 Catalog Number :

Device Description : Tubing Set

Device Class :

Duns Number: 071418804

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00850009362025 Catalog Number :

Device Description : Dosing Set, 100µL

Device Class :

Duns Number: 071418804

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00850009362032 Catalog Number :

Device Description : Subretinal Delivery System Assembly, 100µL

Device Class :

Duns Number: 071418804

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00860000540506 Catalog Number :

Device Description : Subretinal Access Kit - Straight

Device Class : 1

Duns Number: 071418804

Premarket Exempt : No

Product Code : HMX, FMF

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00860000540513 Catalog Number :

Device Description : Subretinal Access Kit - Curved

Device Class : 1

Duns Number: 071418804

Premarket Exempt : No

Product Code : HMX, FMF

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00860000540520 Catalog Number :

Device Description : Subretinal Injection Cannula Set - Straight

Device Class : 1

Duns Number: 071418804

Premarket Exempt : No

Product Code : HMX, FMF

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00860000540537 Catalog Number :

Device Description : Subretinal Injection Cannula Set - Curved

Device Class : 1

Duns Number: 071418804

Premarket Exempt : No

Product Code : HMX, FMF

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00860000540544 Catalog Number :

Device Description : Pouched Syringe Kit

Device Class : 1

Duns Number: 071418804

Premarket Exempt : No

Product Code : HMX, FMF

Prescription Use : Yes

Device Count : 1

Orbit Subretinal Delivery System - 00860000540551 Catalog Number :

Device Description : Trayed Tube Set

Device Class : 1

Duns Number: 071418804

Premarket Exempt : No

Product Code : HMX, FMF

Prescription Use : Yes

Device Count : 1

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