Tracheal Stent with Posts

GUDID 00815347021812

Hood Tracheo-Bronchial Prosthesis

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347021812
NIH Device Record Keybc40eb86-fc94-4578-a661-979865dd22da
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracheal Stent with Posts
Version Model NumberTSP-1560-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
GS100815347021812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347021812]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021812]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021812]

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

On-Brand Devices [Tracheal Stent with Posts]

00815347021911Hood Tracheo-Bronchial Prosthesis
00815347021904Hood Tracheo-Bronchial Prosthesis
00815347021898Hood Tracheo-Bronchial Prosthesis
00815347021881Hood Tracheo-Bronchial Prosthesis
00815347021874Hood Tracheo-Bronchial Prosthesis
00815347021867Hood Tracheo-Bronchial Prosthesis
00815347021850Hood Tracheo-Bronchial Prosthesis
00815347021843Hood Tracheo-Bronchial Prosthesis
00815347021836Hood Tracheo-Bronchial Prosthesis
00815347021829Hood Tracheo-Bronchial Prosthesis
00815347021812Hood Tracheo-Bronchial Prosthesis
00815347021805Hood Tracheo-Bronchial Prosthesis
00815347021799Hood Tracheo-Bronchial Prosthesis
00815347021782Hood Tracheo-Bronchial Prosthesis
00815347021775Hood Tracheo-Bronchial Prosthesis
00815347021768Hood Tracheo-Bronchial Prosthesis

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