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

Mirror, Ent (KAI) (10)

Premarket Exempt

No Yes

Clear

BEAR - G043810010 Catalog Number : 8.10.01

Device Description : Laryngeal Mirror, Rhodium, EC 1 / US 0 (12mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810020 Catalog Number : 8.10.02

Device Description : Laryngeal Mirror, Rhodium, EC 2 / US 1 (14mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810030 Catalog Number : 8.10.03

Device Description : Laryngeal Mirror, Rhodium, EC 3 / US 2 (16mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810040 Catalog Number : 8.10.04

Device Description : Laryngeal Mirror, Rhodium, EC 4 / US 3 (18mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810050 Catalog Number : 8.10.05

Device Description : Laryngeal Mirror, Rhodium, EC 5 / US 4 (20mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810060 Catalog Number : 8.10.06

Device Description : Laryngeal Mirror, Rhodium, EC 6 / US 5 (22mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810070 Catalog Number : 8.10.07

Device Description : Laryngeal Mirror, Rhodium, EC 7 / US 6 (24mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810080 Catalog Number : 8.10.08

Device Description : Laryngeal Mirror, Rhodium, EC 8 / US 7 (26mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810090 Catalog Number : 8.10.09

Device Description : Laryngeal Mirror, Rhodium, EC 9 / US 8 (28mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

BEAR - G043810100 Catalog Number : 8.10.10

Device Description : Laryngeal Mirror, Rhodium, EC 10 / US 9 (30mm)

Device Class : 1

Duns Number: 123551586

Premarket Exempt : Yes

Product Code : KAI

Prescription Use : Yes

Device Count : 1

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