FDA.reportPublic FDA data

ViVi TOGA Premium Size XL-XXL

Primary DI
09009607822207
Brand
ViVi TOGA Premium Size XL-XXL
Company
THI Total Healthcare Innovation GmbH
Model
82220
Catalog number
82220
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19009607822204PackageGS120In Commercial Distribution
09009607822207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1900960782220419009607822204
09009607822207090096078222079009607822207

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
1-858-822-9433vincent.bates@thigmbh.at

Regulatory Flags#

DUNS number
300188850
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09009607811003ViVi® HELMET2581100811002025-11-10
09009607811010ViVi® HELMET25 XL81100XL81100XL2025-11-10
09009607811300ViVi® HELMET25 HPL81130811302025-11-10
09009607811317ViVi® HELMET25 XL HPL81130XL81130XL2025-11-10
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
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
09009607822214ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832213ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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