FDA.reportPublic FDA data

Single Use Professional

Primary DI
05055299101520
Brand
Single Use Professional
Company
EAKIN SURGICAL LIMITED
Model
S112
Catalog number
S112
Device description
Blunt Aspiration Tube 4mm 33cm contains 25 units
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05055299100752PackageGS125In Commercial Distribution
05055299101520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055299100752050552991007525055299100752
05055299101520050552991015205055299101520

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration system pumpA mains electricity (AC-powered) device used to generate positive and/or negative pressures as part of an irrigation/aspiration system used during a general surgical procedure to intermittently or continuously irrigate and/or aspirate body cavities and wounds. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter
Outer Diameter4Millimeter
Outer Diameter5Millimeter

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
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956592919CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-29
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10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08