Channick Y Stent

GUDID 00815347022529

Hood Bifurcated T-Tube

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347022529
NIH Device Record Keye3973431-56f1-4027-87bc-f70adcc77155
Commercial Distribution StatusIn Commercial Distribution
Brand NameChannick Y Stent
Version Model NumberCY-1612-S
Company DUNS076603380
Company NameHOOD, E BENSON LABORATORIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815347022529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347022529]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022529]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022529]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-21

Devices Manufactured by HOOD, E BENSON LABORATORIES INC

00815347020082 - Y-Stent with Tracheal Posts with 1mm Wall Thickness2023-11-29 E. Benson Hood Laboratories Y-Stent
00815347020099 - Y-Stent with Tracheal Posts with 1mm Wall Thickness2023-11-29 E. Benson Hood Laboratories Y-Stent
00815347023762 - Radiopaque Bronchial Stent with Posts2023-11-29 Hood Tracheo-Bronchial Prosthesis
00815347023779 - Radiopaque Bronchial Stent with Posts2023-11-29 Hood Tracheo-Bronchial Prosthesis
00815347023786 - Radiopaque Bronchial Stent with Posts2023-11-29 Hood Tracheo-Bronchial Prosthesis
00815347023793 - Radiopaque Tracheal Stent with Posts2023-11-29 Hood Tracheo-Bronchial Prosthesis
00815347023809 - Radiopaque Tracheal Stent with Posts2023-11-29 Hood Tracheo-Bronchial Prosthesis
00815347023816 - Radiopaque Bronchial Stent with Posts2023-11-29 Hood Tracheo-Bronchial Prosthesis

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