AVALIGN TECHNOLOGIES, INC.

Address:8727 Clinton Park Dr,Fort Wayne,IN,46825,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

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY (GZT) (6) DILATOR, VESSEL, SURGICAL (DWP) (3) Ligator, hemorrhoidal (FHN) (1)

Premarket Exempt

No Yes

Clear

Avalign - 10190776006478 Catalog Number :

Device Description : Gaskets for Hemorrhoidal box of Ligator, silicone, Latex Free

Device Class :

Duns Number: 792528510

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : Yes

Device Count : 100

Avalign - 10190776011199 Catalog Number :

Device Description : Garrett Vascular Dilator, set of 9

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : DWP

Prescription Use : Yes

Device Count : 10

Avalign - 10190776011311 Catalog Number :

Device Description : Garrett Vascular Dilator, set of 9

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : DWP

Prescription Use : Yes

Device Count : 10

Avalign - 10190776011427 Catalog Number :

Device Description : DeBakey Vascular Dilator, set of 12

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : DWP

Prescription Use : Yes

Device Count : 12

Avalign - 10190776015708 Catalog Number :

Device Description : Hoen Retractor Set, 2 sets of blades

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 5

Avalign - 10190776015715 Catalog Number :

Device Description : Hoen Retractor Blades, small

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 2

Avalign - 10190776015852 Catalog Number :

Device Description : Cloward-Style Cervical Retractor, set, 7 pairs blade

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 15

Avalign - 10190776015951 Catalog Number :

Device Description : Cloward Style Cervical Hinged Retractor, set, 7 pairs

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 15

Avalign - 10190776016125 Catalog Number :

Device Description : McCulloch Type Wide Muscle Blade, pair

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 2

Avalign - 10190776016132 Catalog Number :

Device Description : McCulloch Type Wide Muscle Blade, pair

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 2

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