Eagle Labs

Address:10201-A TRADEMARK ST.,Cucamonga,CA,91730,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

Sponge, Ophthalmic (HOZ) (8) Drape, Patient, Ophthalmic (HMT) (2)

Premarket Exempt

Yes

Clear

N/A - 00810090013497 Catalog Number :

Device Description : Non-woven Half Body drape with adhesive incise and fluid collection pouch

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HMT

Prescription Use : Yes

Device Count : 1

N/A - 00810090013510 Catalog Number :

Device Description : PVA Pre-expanded Eye Spears, 2 ea

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090013909 Catalog Number :

Device Description : Eye Pledget, Lint free PVS eye sponges, 2mm x 6mm - 10 in one package

Device Class :

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090013916 Catalog Number :

Device Description : LASIK Drainage Ring, Superior Hinge, 9.5mm opening

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090013923 Catalog Number :

Device Description : LASIK sponge, 11mm opening

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090013961 Catalog Number :

Device Description : LASIK shield, 8mm diameter, 6mm edge

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090013978 Catalog Number :

Device Description : LASIK Shield, Dual Edge, 4mm and 8mm

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090014142 Catalog Number :

Device Description : Non-woven half body drape with adhesive aperture and fluid collection pouch

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HMT

Prescription Use : Yes

Device Count : 1

N/A - 00810090014166 Catalog Number :

Device Description : LASIK Shield, 7mm diameter, 5mm edge

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

N/A - 00810090014203 Catalog Number :

Device Description : PVA Eye Spears, 5 ea

Device Class : 2

Duns Number: 555862549

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

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