Archimedes Access Kit 10009-9

GUDID 00856571007296

A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.

BRONCUS MEDICAL INC.

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Primary Device ID00856571007296
NIH Device Record Key1946f4fc-a0f0-411d-9851-2f0a6b22993e
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchimedes Access Kit
Version Model Number10009-9
Catalog Number10009-9
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com
Phone650-428-1600
EmailCustomerSupport@Broncus.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-12
Device Publish Date2021-10-04

On-Brand Devices [Archimedes Access Kit]

00856571007029A collection of sterile devices designed to access and perform a biopsy sample during a lung bio
00856571007296A collection of sterile devices designed to access and perform a biopsy sample during a lung bio

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