Bronchial Stent with Posts

GUDID 00815347021393

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 ID00815347021393
NIH Device Record Key775e7dde-b0ad-4dfa-acc8-0d27195aabde
Commercial Distribution StatusIn Commercial Distribution
Brand NameBronchial Stent with Posts
Version Model NumberBSP-1030-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
GS100815347021393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347021393]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021393]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021393]

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 Date2015-12-11

On-Brand Devices [Bronchial Stent with Posts]

00815347021478Hood Tracheo-Bronchial Prosthesis
00815347021461Hood Tracheo-Bronchial Prosthesis
00815347021454Hood Tracheo-Bronchial Prosthesis
00815347021447Hood Tracheo-Bronchial Prosthesis
00815347021430Hood Tracheo-Bronchial Prosthesis
00815347021423Hood Tracheo-Bronchial Prosthesis
00815347021416Hood Tracheo-Bronchial Prosthesis
00815347021409Hood Tracheo-Bronchial Prosthesis
00815347021393Hood Tracheo-Bronchial Prosthesis
00815347021386Hood Tracheo-Bronchial Prosthesis

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