Aztecmed/Ent LLC

Aztecmed/Ent LLC

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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

Curette, Ear (JYG) (4) Tube, Ear Suction (JZF) (4) Instrument, Manual, Surgical, General Use (MDM) (2)

Premarket Exempt

Yes

Clear

Aztec - B87110100110 Catalog Number : 10-10011

Device Description : Farrell Triangular Applicator

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Aztec - B87110100120 Catalog Number : 10-10012

Device Description : Farrell Twist Applicator

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Aztec - B87110110210 Catalog Number : 10-11021

Device Description : Antrum Cannula 3mm short curve

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

Aztec - B87110110220 Catalog Number : 10-11022

Device Description : Antrum Cannula 3mm long curve

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

Aztec - B87110110230 Catalog Number : 10-11023

Device Description : Antrum Cannula 4mm short curve

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

Aztec - B87110110240 Catalog Number : 10-11024

Device Description : Antrum Cannula 4mm long curve

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

Aztec - B87110120990 Catalog Number : 10-12099

Device Description : Buck Ear Curette size 00

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

Aztec - B87110121000 Catalog Number : 10-12100

Device Description : Buck Ear Curette size 0

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

Aztec - B87110121010 Catalog Number : 10-12101

Device Description : Buck Ear Curette size 1

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

Aztec - B87110121020 Catalog Number : 10-12102

Device Description : Buck Ear Curette size 2

Device Class : 1

Duns Number: 117559084

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

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