Archimedes Access Key 10009-1

GUDID 00856571007227

Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.

BRONCUS MEDICAL INC.

Virtual bronchoscopic navigation PACS software
Primary Device ID00856571007227
NIH Device Record Key4eea27b2-6247-4b75-a4b8-572a92107689
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchimedes Access Key
Version Model Number10009-1
Catalog Number10009-1
Company DUNS078684808
Company NameBRONCUS MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-428-1600
EmailCustomerSupport@Broncus.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007227 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-23
Device Publish Date2017-12-12

Devices Manufactured by BRONCUS MEDICAL INC.

00856571007913 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007920 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007937 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007944 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007951 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007968 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007975 - BroncTru™ Transbronchial Access Tool2025-04-08
00856571007982 - BroncTru™ Transbronchial Access Tool2025-04-08

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