FDA.reportPublic FDA data

ViVi® HELMET25 XL

Primary DI
09009607811010
Brand
ViVi® HELMET25 XL
Company
THI Total Healthcare Innovation GmbH
Model
81100XL
Catalog number
81100XL
Published
2025-11-10
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
09009607811010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09009607811010090096078110109009607811010

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.

Contacts#

Phone, Email table
PhoneEmail
1-858-822-9433vincebates@ivysurgical.com

Regulatory Flags#

DUNS number
300188850
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09009607811003ViVi® HELMET2581100811002025-11-10
09009607811300ViVi® HELMET25 HPL81130811302025-11-10
09009607811317ViVi® HELMET25 XL HPL81130XL81130XL2025-11-10
09009607822207ViVi TOGA Premium Size XL-XXL82220822202025-06-13
09009607822214ViVi TOGA Premium Size M-L82221822212025-06-13
09009607822221ViVi TOGA Premium Size XXS-S82222822222025-06-13
09009607832206ViVi TOGA Premium Size XL-XXL82220V82220V2025-06-13
09009607832213ViVi TOGA Premium Size M-L82221V82221V2025-06-13
09009607832220ViVi TOGA Premium Size XXS-S82222V82222V2025-06-13
19009607822204ViVi TOGA Premium Size XL-XXL82220822202025-06-13
19009607822211ViVi TOGA Premium Size M-L82221822212025-06-13
19009607822228ViVi TOGA Premium Size XXS-S82222822222025-06-13
19009607832203ViVi TOGA Premium Size XL-XXL82220V82220V2025-06-13
19009607832210ViVi TOGA Premium Size M-L82221V82221V2025-06-13
19009607832227ViVi TOGA Premium Size XXS-S82222V82222V2025-06-13
09009607815001ViVi PEEL-OFF HOOD80500V80500V2025-06-10
19009607815008ViVi PEEL-OFF HOOD80500V80500V2025-06-10
09009607801004ViVi Helmet80100801002023-11-10
09009607801301ViVi Helmet HPL80130801302023-11-10
09009607812000ViVi Hood80200V80200V2023-11-10

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
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
07613154511105NASTRYKER CORPORATIONFXZ2018-09-24
07613154511198NASTRYKER CORPORATIONFXZ2018-09-24
07613154626366NASTRYKER CORPORATIONFXZ2018-09-24
07613154886289FlyteSTRYKER CORPORATIONFXZ2018-09-24
07613154891061FlyteSTRYKER CORPORATIONFXZ2018-09-24