FDA.reportPublic FDA data

Single Use Surgical Professional

Primary DI
05055299106211
Brand
Single Use Surgical Professional
Company
EAKIN SURGICAL LIMITED
Model
S443
Catalog number
S443
Device description
Drainage Cannula 6fg 9cm
Published
2016-08-19
Public version status
Update
Distribution status
Not 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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055299106211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055299106211050552991062115055299106211

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length9Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

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
05055299100776Single Use Professional6fgN1006fgN1002016-08-09
05055299100783Single Use Professional9fgN1009fgN1002016-08-09
05055299100790Single Use Professional6fgN1406fgN1402016-08-09
05055299100806Single Use Professional9fgN1409fgN1402016-08-09
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
Primary DIBrandCompanyProduct codePublished
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00817295020404InradInradGAA2026-10-09
00817295020411InradInradGAA2026-10-09
00817295020428InradInradGAA2026-10-09
00817295020435InradInradGAA2026-10-09
08800165015435ACE CANNULAACE MEDICAL INDUSTRY CO., LTD.GAA2026-10-09