Firefly Global

Firefly Global

Address:464 Common St # 281,Belmont,MA,02478,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

Light, Examination, Medical, Battery Powered (KYT) (4) Camera, Cine, Endoscopic, Without Audio (FWL) (2) Otoscope (ERA) (2) Led Light Source (NTN) (1) Microscope, Operating, Non-Electric, Ophthalmic (HRB) (1)

Premarket Exempt

Yes

Clear

Firefly - 00851289007002 Catalog Number :

Device Description : Compact handheld light source (battery operated)

Device Class : 2

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : NTN

Prescription Use : No

Device Count : 1

Firefly - 00851289007019 Catalog Number :

Device Description : Digital Video Otoscope

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

Firefly - 00851289007026 Catalog Number :

Device Description : Digital Dermatoscope

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : KYT

Prescription Use : No

Device Count : 1

Firefly - 00851289007033 Catalog Number :

Device Description : General Exam Camera

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : KYT

Prescription Use : No

Device Count : 1

Redfin - 00851289007040 Catalog Number :

Device Description : Digital Endoscopic Camera

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : FWL

Prescription Use : No

Device Count : 1

Firefly - 00851289007057 Catalog Number :

Device Description : Digital Endoscopic Camera

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : FWL

Prescription Use : No

Device Count : 1

Firefly - 00851289007064 Catalog Number :

Device Description : Digital Video Otoscope

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

Firefly - 00851289007071 Catalog Number :

Device Description : Digital Dermatoscope

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : KYT

Prescription Use : No

Device Count : 1

Firefly - 00851289007088 Catalog Number :

Device Description : Digital Iris Scope

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : HRB

Prescription Use : No

Device Count : 1

Firefly - 00851289007095 Catalog Number :

Device Description : Digital Trichoscope

Device Class : 1

Duns Number: 020089936

Premarket Exempt : Yes

Product Code : KYT

Prescription Use : No

Device Count : 1

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