FDA.reportPublic FDA data

CORE

Primary DI
07613154499977
Brand
CORE
Company
STRYKER CORPORATION
Model
5400206000
Catalog number
5400-206-000
Device description
Auto Irrigator
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBBMOTOR, DRILL, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613154499977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154499977076131544999777613154499977

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration systemAn assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04251388959954VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959961VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959978VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388960448VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388961001VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
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00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
00763000714499MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714505MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714604MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000930837MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-10-03
00763000714482MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714536MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714550MR8 ToolsMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-04-27
00763000732943MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-01-18