FDA.reportPublic FDA data

OSSEOUS Salivary by Pass Tube

Primary DI
08906039312119
Brand
OSSEOUS Salivary by Pass Tube
Company
EON MEDITECH PRIVATE LIMITED
Model
E31414C
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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCFDilator, Esophageal, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCFDilator, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906039314328PackageGS11In Commercial Distribution
08906039312119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906039314328089060393143288906039314328
08906039312119089060393121198906039312119

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length188Millimeter
Outer Diameter27Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906039312096OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312102OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312126OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312133OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312140OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
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
08906039314304OSSEOUS 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
14063107100281Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100298Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100304Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100311Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100328Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100335Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100342Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100359Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100366Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100373Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29