Straight Stoma Stent with Windows

GUDID 00815347023168

Hood Tracheal Stoma Button

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347023168
NIH Device Record Keydca5b00a-59b3-40b2-90d6-1b8c35202643
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraight Stoma Stent with Windows
Version Model NumberSSW-1319
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
GS100815347023168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347023168]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023168]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023168]

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 Date2016-04-15

On-Brand Devices [Straight Stoma Stent with Windows]

00815347023212Hood Tracheal Stoma Button
00815347023205Hood Tracheal Stoma Button
00815347023199Hood Tracheal Stoma Button
00815347023182Hood Tracheal Stoma Button
00815347023175Hood Tracheal Stoma Button
00815347023168Hood Tracheal Stoma Button
00815347023151Hood Tracheal Stoma Stent
00815347023144Hood Tracheal Stoma Button
00815347023137Hood Tracheal Stoma Button
00815347023120Hood Tracheal Stoma Button
00815347023113Hood Tracheal Stoma Button
00815347023106Hood Tracheal Stoma Button
00815347023090Hood Tracheal Stoma Button
00815347023083Hood Tracheal Stoma Button
00815347023076Hood Tracheal Stoma Button
00815347023069Hood Tracheal Stoma Button
00815347023052Hood Tracheal Stoma Button
00815347023045Hood Tracheal Stoma Button
00815347023038Hood Tracheal Stoma Button

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