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

FORCEPS, SURGICAL, GYNECOLOGICAL (HCZ) (6) RONGEUR, MANUAL (HAE) (4)

Premarket Exempt

No Yes

Clear

Avalign - 00190776000400 Catalog Number :

Device Description : Rogers Hysterectomy Forceps, Straight

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HCZ

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000417 Catalog Number :

Device Description : Rogers Hysterectomy Forceps, Curved

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HCZ

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000424 Catalog Number :

Device Description : Masterson Hysterectomy Forceps, straight, vascular teeth

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HCZ

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000431 Catalog Number :

Device Description : Masterson Hysterectomy Forceps, curved, vascular teeth

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HCZ

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000448 Catalog Number :

Device Description : Z-Clamp Angled Handle, Angled Jaws

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HCZ

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000455 Catalog Number :

Device Description : Schroeder (Braun) Tenaculum, single tooth, Sklar Blue Radial Frequency coated fo Schroeder (Braun) Tenaculum, single tooth, Sklar Blue Radial Frequency coated for electrosurgery

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HCZ

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000462 Catalog Number :

Device Description : Ruskin Rongeur, double action, curved

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HAE

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000479 Catalog Number :

Device Description : Stille Luer Rongeur, curved

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HAE

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000486 Catalog Number :

Device Description : Sella Punch

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HAE

Prescription Use : Yes

Device Count : 1

Avalign - 00190776000493 Catalog Number :

Device Description : Micro Kerrison

Device Class : 2

Duns Number: 792528510

Premarket Exempt : No

Product Code : HAE

Prescription Use : Yes

Device Count : 1

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