FDA.reportPublic FDA data

Mehta Laryngeal Stent

Primary DI
00815347023250
Brand
Mehta Laryngeal Stent
Company
HOOD, E BENSON LABORATORIES INC
Model
MLS-12-S
Device description
E. Benson Hood Laboratories Laryngeal Stent
Published
2016-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FWNProsthesis, Larynx (Stents And Keels)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWNProsthesis, Larynx (Stents And Keels)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841347000LARYNGEAL STENTE. Benson Hood Laboratories, Inc.1984-05-02FWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815347023250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815347023250008153470232508153470232500815347023250

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
076603380
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815347020082Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1512-S2023-11-21
00815347020099Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1814-S2023-11-21
00815347023762Radiopaque Bronchial Stent with PostsRBSP1-1030-S2023-11-21
00815347023779Radiopaque Bronchial Stent with PostsRBSP1-1230-S2023-11-21
00815347023786Radiopaque Bronchial Stent with PostsRBSP1-1240-S2023-11-21
00815347023793Radiopaque Tracheal Stent with PostsRTSP-1450-S2023-11-21
00815347023809Radiopaque Tracheal Stent with PostsRTSP-1650-S2023-11-21
00815347023816Radiopaque Bronchial Stent with PostsRBSP1-1250-S2023-11-21
00815347024011Radiopaque Hour Glass Stent with PostsRHGS-1614-S2023-11-21
00815347024028Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1410-S2023-11-21
00815347024035Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1613-S2023-11-21
00815347020358Extra Long Tracheal T-TubeELT-06-S2015-10-27
00815347020365Long Tracheal T-TubeLT-506-S2015-10-27
00815347020372Long Tracheal T-TubeLT-507-S2015-10-27
00815347020389Extra Long Tracheal T-TubeELT-07-S2015-10-27
00815347020396Extra Long Tracheal T-TubeELT-08-S2015-10-27
00815347020402Long Tracheal T-TubeLT-508-S2015-10-27
00815347020419Extra Long Tracheal T-TubeELT-10-S2015-10-27
00815347020426Long Tracheal T-TubeLT-509-S2015-10-27
00815347020433Long Tracheal T-TubeLT-510-S2015-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14063107101646Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101653Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101660Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101677Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101684Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101691Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101707Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101714Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101721Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101738Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107100441Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100465Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100472Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100489Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100496Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100502Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100519Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100526Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100533Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100540Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100445Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100469Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100476Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100483Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100490Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100506Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100513Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100520Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100537Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100544Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29