Curved Stoma Stent

GUDID 00815347023014

Hood Tracheal Stoma Button

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347023014
NIH Device Record Key4b255309-c138-4651-8d24-4d1ac8970b2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurved Stoma Stent
Version Model NumberCS-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
GS100815347023014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347023014]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023014]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023014]

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 [Curved Stoma Stent]

00815347023014Hood Tracheal Stoma Button
00815347023007Hood Tracheal Stoma Button
00815347022994Hood Tracheal Stoma Button
00815347022970Hood Tracheal Stoma Button
00815347022963Hood Tracheal Stoma Button
00815347022956Hood Tracheal Stoma Button
00815347022949Hood Tracheal Stoma Button
00815347022925Hood Tracheal Stoma Button

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