FDA.report

OSSEOUS Salivary by Pass Tube

Primary DI
08906039314304
Brand
OSSEOUS Salivary by Pass Tube
Company
EON MEDITECH PRIVATE LIMITED
Model
E31410W
Device description
"Salivary by-pass Tube directs saliva which discharges from neck wound after surgery into the distal esophagus and to facilitate the management of fistula resulting from a variety of causes including advanced malignancy, surgery, radiation, trauma and caustic ingestion.
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KCFDilator, Esophageal, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCFDilator, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906039314304PackageGS11In Commercial Distribution
08906039312126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906039314304089060393143048906039314304
08906039312126089060393121268906039312126

GMDN Terms

TermDefinition
Polymeric oesophageal stent, non-bioabsorbableA sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to temporarily maintain luminal patency in strictures and achalasia, seal fistulas, and/or to treat other lesions (e.g., anastomotic leaks). It is a mesh structure, which may or may not be covered/lined, and is made entirely of a synthetic polymer(s) (e.g., silicone). It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes

TypeValueUnit
Length188Millimeter
Outer Diameter24Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
930270428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13
08904428799749OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428798292OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461030892OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055024OSSEOUS-SnorOFFE317012026-03-13
08904428798377OSSEOUS-CapsuleEA9100182026-03-13
08904428747672OSSEOUS Blade - Inferior turbinate - N TypeEI22222024-07-10
08904428747665OSSEOUS Blade - Inferior turbinate - N TypeEI22212024-07-10
08904428747658OSSEOUS Blade-Straight Sinus Blades - N TypeEI22202024-07-10
08904428747641OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22192024-07-10
08904428747634OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22182024-07-10
08904428747627OSSEOUS Blade-Curved Sinus Blades - TypeEI22172024-07-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08906039314366OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314342OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314328OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314281OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314267OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
G422DL0030MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MMBIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL1010DILATOR CERVICAL SET OF 6BIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRBIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)BIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
00827002352674HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352681HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352698HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352704HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352711HerculesCOOK INCORPORATEDKCF2022-12-20
34063107100285Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100292Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100308Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100315Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100322Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100339Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100346Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100353Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100360Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100377Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100384Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100391Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100407Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100414Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100421Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
34063107100438Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29