FDA.reportPublic FDA data

OSSEOUS Suction tubes for Throat

Primary DI
08906039315110
Brand
OSSEOUS Suction tubes for Throat
Company
EON MEDITECH PRIVATE LIMITED
Model
EI1620250
Device description
Suction tubes for Throat are used to remove excess amount of foreign body material from throat.
Published
2024-06-25
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
KCBTube, Tonsil Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCBTube, Tonsil SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906039318395PackageGS110In Commercial Distribution
08906039315110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906039318395089060393183958906039318395
08906039315110089060393151108906039315110

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Length250Millimeter
Outer Diameter2Millimeter

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD920223100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9204111140Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9227771100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD49301300Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD4930130450Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD61042070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD6786020Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430081A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD91143014A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911431107A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511180Surgical DirectSurgical Direct, Inc.KCB2026-02-05
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B382SD9114511500Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511680Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911454070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860310Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860320Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860330Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860340Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430150Surgical DirectSurgical Direct, Inc.KCB2025-12-02
B382SD471400820Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114311000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114312000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114511830Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911451185A0Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911500010Surgical DirectSurgical Direct, Inc.KCB2025-11-05