FDA.reportPublic FDA data

Huang Inner Ear Shunt

Primary DI
00815347023601
Brand
Huang Inner Ear Shunt
Company
HOOD, E BENSON LABORATORIES INC
Model
GS-2000
Device description
Gibson Endolymphatic Shunt
Published
2016-07-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ESZTube, Shunt, Endolymphatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESZTube, Shunt, EndolymphaticEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K897049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K897049000GIBSON ENDOLYMPHATIC SHUNTHood Laboratories1990-03-16ESZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815347023601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815347023601008153470236018153470236010815347023601

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. 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
Serial number
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
00815347023588Inner Ear Valved ShuntHOOD, E BENSON LABORATORIES INCESZ2016-07-07
00681490035798AustinMEDTRONIC XOMED, INC.ESZ2015-06-25
00681490035897AustinMEDTRONIC XOMED, INC.ESZ2015-06-25
00681490036115PulecMEDTRONIC XOMED, INC.ESZ2015-06-25