FDA.reportPublic FDA data

ELITE MEDICAL INSTRUMENTATION

Primary DI
G569EMIMB286R0
Brand
ELITE MEDICAL INSTRUMENTATION
Company
ELITE MEDICAL INSTRUMENTATION
Model
EMI-MB286R
Catalog number
EMI-MB286R SUCTION TIP
Device description
"Suction Tip, Grafting, 3mm, 9 1/2"""
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G569EMIMB286R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116733674
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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G569EMIBB077R0ELITE MEDICAL INSTRUMENTATIONEMI-BB077REMI-BB077R KNIFE HANDLE2024-03-22
G569EMIBC547R0ELITE MEDICAL INSTRUMENTATIONEMI-BC547REMI-BC547R SCISSORS2024-03-22
G569EMIBC557R0ELITE MEDICAL INSTRUMENTATIONEMI-BC557REMI-BC557R SCISSORS2024-03-22
G569EMIBC648R0ELITE MEDICAL INSTRUMENTATIONEMI-BC648REMI-BC648R SCISSORS2024-03-22
G569EMIBC677R0ELITE MEDICAL INSTRUMENTATIONEMI-BC677REMI-BC677R SCISSORS2024-03-22
G569EMIBM004R0ELITE MEDICAL INSTRUMENTATIONEMI-BM004REMI-BM004R NEEDLE HOLDER2024-03-22
G569EMIBM047R0ELITE MEDICAL INSTRUMENTATIONEMI-BM047REMI-BM047R NEEDLE HOLDER2024-03-22
G569EMIBM055R0ELITE MEDICAL INSTRUMENTATIONEMI-BM055REMI-BM055R NEEDLE HOLDER2024-03-22
G569EMIBM058R0ELITE MEDICAL INSTRUMENTATIONEMI-BM058REMI-BM058R NEEDLE HOLDER2024-03-22
G569EMIBM066R0ELITE MEDICAL INSTRUMENTATIONEMI-BM066REMI-BM066R NEEDLE HOLDER2024-03-22
G569EMIBT470R0ELITE MEDICAL INSTRUMENTATIONEMI-BT470REMI-BT470R RETRACTOR2024-03-22
G569EMIBT611R0ELITE MEDICAL INSTRUMENTATIONEMI-BT611REMI-BT611R RETRACTOR2024-03-22
G569EMIBT614R0ELITE MEDICAL INSTRUMENTATIONEMI-BT614REMI-BT614R RETRACTOR2024-03-22
G569EMIBT756R0ELITE MEDICAL INSTRUMENTATIONEMI-BT756REMI-BT756R RETRACTOR2024-03-22
G569EMIBT763R0ELITE MEDICAL INSTRUMENTATIONEMI-BT763REMI-BT763R2024-03-22
G569EMIKTS1040ELITE MEDICAL INSTRUMENTATIONEMI-KTS1-04EMI-KTS1-04 SPECULUM2024-03-22
G569EMI3535350ELITE MEDICAL INSTRUMENTATIONEMI-35-3535EMI-35-3535 CLAMP2024-03-21
G569EMI3536310ELITE MEDICAL INSTRUMENTATIONEMI-353631EMI-353631 CLAMP2024-03-21

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