FDA.reportPublic FDA data

NA

Primary DI
07613327291896
Brand
NA
Company
STRYKER MEDTECH K.K.
Model
5450850028
Catalog number
5450-850-028
Device description
IV Pole
Published
2018-09-24
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
FOXSTAND, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327291896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327291896076133272918967613327291896

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
690682147
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327290202NA54508250005450-825-0002016-09-23
07613327291803NA54508040005450-804-0002018-09-24
07613327291827NA54508060005450-806-0002018-09-24
07613327291872Sonopet54508500005450-850-0002018-09-24
07613327291933NA54508400005450-840-0002018-09-24
07613327291940NA54508500075450-850-0072018-09-24
07613327291919NA54508200005450-820-0002018-09-24
07613327289886NA54508000405450-800-0402016-09-23
07613327289893Hyper LT54508140005450-814-0002018-09-24
07613327291537NA54508002765450-800-2762018-09-24
07613327291483NA54508000245450-800-0242018-09-24
07613327291520NA54508000385450-800-0382018-09-24
07613327291490NA545080003054508000302018-09-24
07613327291568NA545080002954508000292018-09-24
07613327291575NA545080002554508000252018-09-24
07613327291957Hyper LT54508110005450-811-0002018-09-24

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Primary DI, Brand, Company table
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00628678604209Pump Carrier - 200 SeriesTechnimount Medicale IncFOX2026-10-21
00761887005549PryorPRYOR PRODUCTSFOX2026-10-16
00810050863667Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-10-14
00810050863674Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-10-14
00810050863650Triple Litter Stacking System (TLSS)LIFEPORT, LLCFOX2026-10-12
00810050863643Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-10-09
00761887005525CorCytePRYOR PRODUCTSFOX2026-10-06
00761887005501CorCytePRYOR PRODUCTSFOX2026-10-01
00761887005532PryorPRYOR PRODUCTSFOX2026-10-01
00761887005518CorCytePRYOR PRODUCTSFOX2026-09-28
00810050863629Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-22
00628678604124Micro Base ProTechnimount Medicale IncFOX2026-09-21
00628678604131PS5000 Clamp Block FQTechnimount Medicale IncFOX2026-09-21
00628678604148Bracket Pro Serie® 350 – MDTechnimount Medicale IncFOX2026-09-21
00628678604155Bracket Pro Serie® 360 - FQTechnimount Medicale IncFOX2026-09-21
00628678604162Bracket Pro Serie® 71Technimount Medicale IncFOX2026-09-21
00628678604179O2 Mount PS5000Technimount Medicale IncFOX2026-09-21
00628678604186Bracket Pro Serie® 26 – FQTechnimount Medicale IncFOX2026-09-21
00628678604193CARDIATEK®Technimount Medicale IncFOX2026-09-21
00810050863612Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-21
00628678604087ContinuuMed™ RIVTechnimount Medicale IncFOX2026-09-18
00628678604094ContinuuMed™ PVTTechnimount Medicale IncFOX2026-09-18
00628678604100Standard Surface BaseTechnimount Medicale IncFOX2026-09-18
00628678604117Universal BaseTechnimount Medicale IncFOX2026-09-18
00810050863544Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863551IV PoleLIFEPORT, LLCFOX2026-08-25
00810050863568Arch InstallationLIFEPORT, LLCFOX2026-08-25