Bear-Ent, LLC

Address:274 Lancaster Ave., Suite 208,Malvern,PA,19355,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

Cannula, Sinus (KAM) (5) Tube, Ear Suction (JZF) (3) Catheter And Tip, Suction (JOL) (2)

Premarket Exempt

Yes No

Clear

BEAR - G043104120 Catalog Number : 1.04.12

Device Description : Curved Sinus Suction, Frazier Handle, 8 Fr, Long

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

BEAR - G043104130 Catalog Number : 1.04.13

Device Description : Curved Sinus Suction, Frazier Handle, 10 Fr, Short

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

BEAR - G043104140 Catalog Number : 1.04.14

Device Description : Curved Sinus Suction, Frazier Handle, 10 Fr, Long

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

BEAR - G043104150 Catalog Number : 1.04.15

Device Description : Curved Sinus Suction, Frazier Handle, 12 Fr, Short

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

BEAR - G043104160 Catalog Number : 1.04.16

Device Description : Curved Sinus Suction, Frazier Handle, 12 Fr, Long

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAM

Prescription Use : Yes

Device Count : 1

BEAR - G043106010 Catalog Number : 1.06.01

Device Description : Andrews-Pynchon Suction w Tip

Device Class : 2

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

BEAR - G043107010 Catalog Number : 1.07.01

Device Description : Yankauer Suction w Tip

Device Class : 2

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

BEAR - G043109090 Catalog Number : 1.09.09

Device Description : Barnes Hospital Suction Tube, 9 Fr

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : Yes

Device Count : 1

BEAR - G043111200 Catalog Number : 1.11.20

Device Description : Schuknecht Suction, 20 Gauge

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : Yes

Device Count : 1

BEAR - G043111220 Catalog Number : 1.11.22

Device Description : Schuknecht Suction, 22 Gauge

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : Yes

Device Count : 1

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