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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (6) DILATOR, VESSEL, SURGICAL (DWP) (1) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

Millennium - 10190776083400 Catalog Number :

Device Description : S-Retractor, pair, Set of 2

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Millennium - 10190776083417 Catalog Number :

Device Description : S-Retractor, pair, Set of 2

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Millennium - 10190776083424 Catalog Number :

Device Description : Hasson S-Retractor, Set of 2

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Millennium - 10190776083431 Catalog Number :

Device Description : Hasson S-Retractor, Set of 2

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Millennium - 10190776083448 Catalog Number :

Device Description : Hasson S-Retractor, Set of 2

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Millennium - 10190776083455 Catalog Number :

Device Description : Hasson S-Retractor, Set of 2

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Millennium - 10190776086579 Catalog Number :

Device Description : Debakey Vascular Dilators, set of 12

Device Class :

Duns Number: 792528510

Premarket Exempt : No

Product Code : DWP

Prescription Use : Yes

Device Count : 12

Millennium - 10190776129399 Catalog Number :

Device Description : S-Retractor, pair, Set of 2

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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