Straight Stoma Stent

GUDID 00815347022871

Hood Tracheal Stoma Button

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347022871
NIH Device Record Key3ace9a6a-a562-42b0-9f9b-db6217939150
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraight Stoma Stent
Version Model NumberSS-1324
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
GS100815347022871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347022871]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022871]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022871]

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 Date2016-04-14

On-Brand Devices [Straight Stoma Stent]

00815347022932Hood Tracheal Stoma Button
00815347022918Hood Tracheal Stoma Button
00815347022901Hood Tracheal Stoma Button
00815347022895Hood Tracheal Stoma Button
00815347022871Hood Tracheal Stoma Button
00815347022864Hood Tracheal Stoma Button
00815347022857Hood Tracheal Stoma Button
00815347022833Hood Tracheal Stoma Button
00815347022826Hood Tracheal Stoma Button
00815347022819Hood Tracheal Stoma Button
00815347022802Hood Tracheal Stoma Button
00815347022796Hood Tracheal Stoma Button
00815347022789Hood Tracheal Stoma Button
00815347022772Hood Tracheal Stoma Button
00815347022765Hood Tracheal Stoma Button
00815347022758Hood Tracheal Stoma Button
00815347022741Hood Tracheal Stoma Button
00815347022734Hood Tracheal Stoma Button
00815347022727Hood Tracheal Stoma Button
00815347022710Hood Tracheal Stoma Button

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