FDA.reportPublic FDA data

Single Use Professional

Primary DI
05055299100806
Brand
Single Use Professional
Company
EAKIN SURGICAL LIMITED
Model
9fgN140
Catalog number
9fgN140
Device description
Frazier Suction 9fg 9cm
Published
2016-08-09
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
05055299100059PackageGS125In Commercial Distribution
05055299100806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055299100059050552991000595055299100059
05055299100806050552991008065055299100806

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge9French
Length9Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+440292074740contactus@pelicanfh.co.uk
+440292074740QARA@eakinhealthcare.com

Regulatory Flags#

DUNS number
239505063
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
05055299101186Single Use Surgical ProfessionalS044S0442016-08-19
05055299106211Single Use Surgical ProfessionalS443S4432016-08-19
05055299100776Single Use Professional6fgN1006fgN1002016-08-09
05055299100783Single Use Professional9fgN1009fgN1002016-08-09
05055299100790Single Use Professional6fgN1406fgN1402016-08-09
05055299100813Single Use Professional6fgF1406fgF1402016-08-09
05055299100820Single Use Professional9fgF1409fgF1402016-08-09
05055299100837Single Use ProfessionalS001S0012016-08-09
05055299100844Single Use ProfessionalS002S0022016-08-09
05055299100851Single Use ProfessionalS005S0052016-08-09
05055299100868Single Use ProfessionalS007S0072016-08-09
05055299100875Single Use ProfessionalS008S0082016-08-09
05055299100899Single Use ProfessionalS010S0102016-08-09
05055299100905Single Use ProfessionalS011S0112016-08-09
05055299100912Single Use ProfessionalS012S0122016-08-09
05055299100929Single Use ProfessionalS013S0132016-08-09
05055299100936Single Use ProfessionalS014S0142016-08-09
05055299100943Single Use ProfessionalS015S0152016-08-09
05055299100981Single Use ProfessionalS019S0192016-08-19
05055299100998Single Use ProfessionalS020S0202016-08-09

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Primary DI, Brand, Company table
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