Westaby T-Y Stent

GUDID 00815347022543

Hood Bifurcated T-Tube

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use
Primary Device ID00815347022543
NIH Device Record Keyb15cd619-5996-479b-a82c-f75036c4d9db
Commercial Distribution StatusIn Commercial Distribution
Brand NameWestaby T-Y Stent
Version Model NumberRTY-12-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
GS100815347022543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347022543]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022543]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347022543]

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 [Westaby T-Y Stent]

00815347022567Hood Bifurcated T-Tube
00815347022550Hood Bifurcated T-Tube
00815347022543Hood Bifurcated T-Tube
00815347022536Hood Bifurcated T-Tube

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