Bronchial Stent with Rings

GUDID 00815347021348

Hood Tracheo-Bronchial Prosthesis

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347021348
NIH Device Record Key542b69a1-fc09-4ec1-8b26-a2cc2be0be14
Commercial Distribution StatusIn Commercial Distribution
Brand NameBronchial Stent with Rings
Version Model NumberBS-0819-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
GS100815347021348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347021348]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021348]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347021348]

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 Rings]

00815347021379Hood Tracheo-Bronchial Prosthesis
00815347021362Hood Tracheo-Bronchial Prosthesis
00815347021355Hood Tracheo-Bronchial Prosthesis
00815347021348Hood Tracheo-Bronchial Prosthesis
00815347021331Hood Tracheo-Bronchial Prosthesis
00815347021324Hood Tracheo-Bronchial Prosthesis
00815347021317Hood Tracheo-Bronchial Prosthesis
00815347020853Hood Tracheo-Bronchial Prosthesis

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