FDA.reportPublic FDA data

NA

Primary DI
04546540494153
Brand
NA
Company
STRYKER CORPORATION
Model
0400645000
Catalog number
0400645000
Device description
T5 Surgical Helmet with Battery Powered Headlight
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXZHELMET, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXZHelmet, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540494153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540494153045465404941534546540494153

GMDN Terms#

Term, Definition table
TermDefinition
Surgical helmet systemA system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.

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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
00850024195134MOLLIMS-00009MM10122022-06-27
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327624069EchoECHO100100-01ECHO100100-012025-01-24
07613327624083EchoECHO100105-01ECHO100105-012025-01-24
07613327624106Broadway 8BRW084132-01BRW084132-012025-01-24
07613327561210Stroke Fast PackAXS2PK07404601AXS2PK074046012023-07-14
07613327561227Stroke Fast PackAXS2PK07104601AXS2PK071046012023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078013026MAXAIRSyntech, Int'l Inc.FXZ2026-04-24
00850078013064MAXAIRSyntech, Int'l Inc.FXZ2026-04-24
09009607811003ViVi® HELMET25THI Total Healthcare Innovation GmbHFXZ2025-11-10
09009607811010ViVi® HELMET25 XLTHI Total Healthcare Innovation GmbHFXZ2025-11-10
09009607811300ViVi® HELMET25 HPLTHI Total Healthcare Innovation GmbHFXZ2025-11-10
09009607811317ViVi® HELMET25 XL HPLTHI Total Healthcare Innovation GmbHFXZ2025-11-10
07613327625134Steri-ShieldSTRYKER CORPORATIONFXZ2025-02-26
07613327627039STERI-SHIELDSTRYKER CORPORATIONFXZ2025-02-26
07613327461312N/ASTRYKER CORPORATIONFXZ2020-08-06
07613327461336N/ASTRYKER CORPORATIONFXZ2020-08-06
00840277124159Innomed, Inc.INNOMED, INC.FXZ2020-05-18
04546540152558NASTRYKER CORPORATIONFXZ2018-09-24
04546540489579NASTRYKER CORPORATIONFXZ2018-09-24
04546540505019NASTRYKER CORPORATIONFXZ2018-09-24
04546540591579FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591593FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591609FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591623FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591630FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591647FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591654NASTRYKER CORPORATIONFXZ2018-09-24
04546540670069NASTRYKER CORPORATIONFXZ2018-09-24
04546540903839NASTRYKER CORPORATIONFXZ2018-09-24
04546540903877NASTRYKER CORPORATIONFXZ2018-09-24
07613154368167NASTRYKER CORPORATIONFXZ2018-09-24
07613154511105NASTRYKER CORPORATIONFXZ2018-09-24
07613154511198NASTRYKER CORPORATIONFXZ2018-09-24
07613154626366NASTRYKER CORPORATIONFXZ2018-09-24
07613154886289FlyteSTRYKER CORPORATIONFXZ2018-09-24
07613154891061FlyteSTRYKER CORPORATIONFXZ2018-09-24