Bronchial Stent with Mesh and Posts

GUDID 00815347021492

Hood Tracheo-Bronchial Prosthesis

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use
Primary Device ID00815347021492
NIH Device Record Key382fe5a7-38f4-4e37-9e19-efe42a7ad6eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameBronchial Stent with Mesh and Posts
Version Model NumberBSP-1030-M-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
GS100815347021492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347021492]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021492]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021492]

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 Date2015-12-18

On-Brand Devices [Bronchial Stent with Mesh and Posts]

00815347021577Hood Tracheo-Bronchial Prosthesis
00815347021560Hood Tracheo-Bronchial Prosthesis
00815347021553Hood Tracheo-Bronchial Prosthesis
00815347021546Hood Tracheo-Bronchial Prosthesis
00815347021539Hood Tracheo-Bronchial Prosthesis
00815347021522Hood Tracheo-Bronchial Prosthesis
00815347021515Hood Tracheo-Bronchial Prosthesis
00815347021508Hood Tracheo-Bronchial Prosthesis
00815347021492Hood Tracheo-Bronchial Prosthesis
00815347021485Hood Tracheo-Bronchial Prosthesis

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