FDA.reportPublic FDA data

OMT LLC

Primary DI
M731RT15100
Brand
OMT LLC
Company
OMT, LLC
Model
Round Tip
Catalog number
RT-1510
Device description
Atraumatic-Malleable Disposable Suction; Sterile; 15 French [W]; 110mm [L]
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M731RT15100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-327-5687regulatory@omtmedical.com

Regulatory Flags#

DUNS number
196899772
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M731K90019Spetzler Neuro PattiesK SeriesK-90012025-12-31
M731K90049Spetzler Neuro PattiesK SeriesK-90042025-12-31
M731K90059Spetzler Neuro PattiesK SeriesK-90052025-12-31
M731K90069Spetzler Neuro PattiesK SeriesK-90062025-12-31
M731K90079Spetzler Neuro PattiesK SeriesK-90072025-12-31
M731K90089Spetzler Neuro PattiesK SeriesK-90082025-12-31
M731K90099Spetzler Neuro PattiesK SeriesK-90092025-12-31
M731K90109Spetzler Neuro PattiesK SeriesK-90102025-12-31
M731K90159Spetzler Neuro PattiesK SeriesK-90152025-12-31
M731K90169Spetzler Neuro PattiesK SeriesK-90162025-12-31
M731K90179Spetzler Neuro PattiesK SeriesK-90172025-12-31
M731K90189Spetzler Neuro PattiesK SeriesK-90182025-12-31
M731K90199Spetzler Neuro PattiesK SeriesK-90192025-12-31
M731K90209Spetzler Neuro PattiesK SeriesK-90202025-12-31
M731K90219Spetzler Neuro PattiesK SeriesK-90212025-12-31
M731K90229Spetzler Neuro PattiesK SeriesK-90222025-12-31
M731K90239Spetzler Neuro PattiesK SeriesK-90232025-12-31
M731K90269Spetzler Neuro PattiesK SeriesK-90262025-12-31
M731K90279Spetzler Neuro PattiesK SeriesK-90272025-12-31
M731K90289Spetzler Neuro PattiesK SeriesK-90282025-12-31

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Primary DI, Brand, Company table
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