FDA.reportPublic FDA data

Flyte

Primary DI
04546540591630
Brand
Flyte
Company
STRYKER CORPORATION
Model
0408655200
Catalog number
0408655200
Device description
Charger Software Upgrade Kit
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
04546540591630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540591630045465405916304546540591630

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.

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
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327651188VersiQuad0234112600234-112-6002026-07-22
07613252193791Neuroform3M003SNF325150M003SNF3251502015-05-29
07613252193845Neuroform3M003SNF335100M003SNF3351002015-05-29
07613252193913Neuroform3M003SNF345100M003SNF3451002015-05-29
07613154599127NA59200002045920-000-2042018-09-24
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24

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
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