Archimedies Access Kit with Syringe 10009-09

GUDID 00856571007234

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

BRONCUS MEDICAL INC.

Lung biopsy procedure kit
Primary Device ID00856571007234
NIH Device Record Key093a6a0b-4e29-4a55-bd42-4a8492690034
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchimedies Access Kit with Syringe
Version Model Number12196-09
Catalog Number10009-09
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007234 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-14

Devices Manufactured by BRONCUS MEDICAL INC.

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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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