C F M TECHNOLOGIES INC

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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

Laryngoscope, Rigid (CCW) (5) Curette, Ear (JYG) (4) Magnet, Permanent (HPN) (3) Otoscope (ERA) (2)

Premarket Exempt

No Yes

Clear

CFM TEechnologies - 00850013958108 Catalog Number : CM3-BK

Device Description : Cerumen Management Set with single-use curettes.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958115 Catalog Number : CM3-BL

Device Description : Cerumen Management Set with single-use curettes.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : No

Product Code : JYG

Prescription Use : No

Device Count : 1

Wizard Wand - 00850013958122 Catalog Number :

Device Description : Wizard Wand Professional Eye Care Set. This kit contains a versatile set of com Wizard Wand Professional Eye Care Set. This kit contains a versatile set of components designed to facilitate effective examination of the eyes for foreign bodies and corneal abrasions and removal of foreign bodies from the conjunctiva.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : HPN

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958139 Catalog Number : ENT-BFK

Device Description : Basic ENT Field. This kit contains a versatile set of components designed to fa Basic ENT Field. This kit contains a versatile set of components designed to facilitate effective examination of the eyes, ears, nose and throat.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : HPN, JYG, ERA

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958146 Catalog Number : ENT-DFK

Device Description : Deluxe ENT Field Kit. This kit contains a versatile set of components designed Deluxe ENT Field Kit. This kit contains a versatile set of components designed to facilitate effective examination of the eyes, ears, nose and throat.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : HPN, JYG, ERA

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958153 Catalog Number :

Device Description : Special Operation Laryngoscope Set.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958160 Catalog Number : ENT-LS7

Device Description : Tactical Laryngoscope Set

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958177 Catalog Number : LB-SU-C4

Device Description : Laryngoscope Blade, single-use, fiber optic, Macintosh 4

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958184 Catalog Number : LB-SU-C3

Device Description : Laryngoscope Blade, single-use, fiber optic, Macintosh 3

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958191 Catalog Number : LB-SU-C2

Device Description : Laryngoscope Blade, single-use, fiber optic, Macintosh 2

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

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