Radiopaque Bronchial Stent with Posts

GUDID 00815347023762

Hood Tracheo-Bronchial Prosthesis

HOOD, E BENSON LABORATORIES INC

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID00815347023762
NIH Device Record Key0f77d693-c8b8-4a60-b41a-1ba43b043cb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadiopaque Bronchial Stent with Posts
Version Model NumberRBSP1-1030-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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815347023762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347023762]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-29
Device Publish Date2023-11-21

On-Brand Devices [Radiopaque Bronchial Stent with Posts]

00815347023816Hood Tracheo-Bronchial Prosthesis
00815347023786Hood Tracheo-Bronchial Prosthesis
00815347023779Hood Tracheo-Bronchial Prosthesis
00815347023762Hood Tracheo-Bronchial Prosthesis

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