Radiopaque Tracheal Stent with Posts

GUDID 00815347023793

Hood Tracheo-Bronchial Prosthesis

HOOD, E BENSON LABORATORIES INC

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID00815347023793
NIH Device Record Keyba666d3a-bf2b-4670-8c63-4782f6934c2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadiopaque Tracheal Stent with Posts
Version Model NumberRTSP-1450-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
GS100815347023793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347023793]

Moist Heat or Steam Sterilization;Ethylene Oxide


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 Tracheal Stent with Posts]

00815347023809Hood Tracheo-Bronchial Prosthesis
00815347023793Hood Tracheo-Bronchial Prosthesis

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