BRONCUS MEDICAL INC.

Address:125 Nicholson Ln,San Jose,CA,95134,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

Bronchoscope (Flexible Or Rigid) (EOQ) (5) System, Image Processing, Radiological (LLZ) (5)

Premarket Exempt

Clear

FleXNeedle - 00856571007012 Catalog Number : 10005-1

Device Description : Single use coring needle for retrieval of tissue samples. It is placed through

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Archimedes Access Kit - 00856571007029 Catalog Number : 10009

Device Description : A collection of sterile devices designed to access and perform a biopsy sample d

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Archimedes System - 00856571007036 Catalog Number : 40005

Device Description : Archimedes software is installed on a desktop computer used to plan procedures a

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Archimedes Sheath - 00856571007067 Catalog Number : 10007

Device Description : A sterile single use flexible tube that provides a working channel during a bron

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Archimedes Dilation Balloon - 00856571007074 Catalog Number : 10008

Device Description : A sterile single use flexible tube with a balloon at or near the distal tip that

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Archimedes Planning System - 00856571007104 Catalog Number : 40009

Device Description : Archimedes Planning Software is software installed on a laptop computer used for

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

LungPoint Planning System, v3.2 - 00856571007128 Catalog Number : 30009

Device Description : LungPoint Planning Software is software installed on a laptop computer used for

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

LungPoint VBN System, V3.2 - 00856571007173 Catalog Number : 30005

Device Description : LungPoint VBN Software is software installed on a desktop computer used to plan

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

FleXNeedle (5 pack) - 00856571007210 Catalog Number : 10005-2

Device Description : Single use coring needle for retrieval of tissue samples. It is placed through

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Archimedes Access Key - 00856571007227 Catalog Number : 10009-1

Device Description : Archimedes Planning Software is software installed on a laptop computer used for

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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