FDA.reportPublic FDA data

NA

Primary DI
07613154511105
Brand
NA
Company
STRYKER CORPORATION
Model
0400610000S3
Catalog number
0400610000S3
Device description
T5 XL Surgical Helmet
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
07613154511105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154511105076131545111057613154511105

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

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
04546540494153NASTRYKER 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
07613154511198NASTRYKER CORPORATIONFXZ2018-09-24
07613154626366NASTRYKER CORPORATIONFXZ2018-09-24
07613154886289FlyteSTRYKER CORPORATIONFXZ2018-09-24
07613154891061FlyteSTRYKER CORPORATIONFXZ2018-09-24