Harrell Y Stent with Posts

GUDID 00815347022475

Hood Tracheo-Bronchial Prosthesis

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347022475
NIH Device Record Key90bd094f-9329-46b1-8e5a-7e094f1685a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarrell Y Stent with Posts
Version Model NumberHYP-16-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
GS100815347022475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347022475]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022475]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022475]

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 [Harrell Y Stent with Posts]

00815347022475Hood Tracheo-Bronchial Prosthesis
00815347022468Hood Tracheo-Bronchial Prosthesis
00815347022451Hood Tracheo-Bronchial Prosthesis
00815347022444Hood Tracheo-Bronchial Prosthesis
00815347022437Hood Tracheo-Bronchial Prosthesis

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