Archimedes Sheath 10007

GUDID 00856571007067

A sterile single use flexible tube that provides a working channel during a bronchoscopic procedure through which other devices may be introduced to the targeted area within the respiratory organs. The sheath is advanced through the working channel of a bronchoscope and allows for the repeated placement of endoscopic devices to a specified lesion(s) during a procedure.

BRONCUS MEDICAL INC.

Bronchoscopic catheter
Primary Device ID00856571007067
NIH Device Record Key76631369-cfd9-47fb-9f80-5ed35dc24e1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchimedes Sheath
Version Model Number10007
Catalog Number10007
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

Device Dimensions

Outer Diameter2.6 Millimeter
Outer Diameter2.6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007067 [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 Number4
Public Version Date2019-02-22
Device Publish Date2017-06-27

Devices Manufactured by BRONCUS MEDICAL INC.

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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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