FDA.reportPublic FDA data

ViVi PEEL-OFF HOOD

Primary DI
09009607815001
Brand
ViVi PEEL-OFF HOOD
Company
THI Total Healthcare Innovation GmbH
Model
80500V
Catalog number
80500V
Published
2025-06-10
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
FXYHood, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19009607815008PackageGS120In Commercial Distribution
09009607815001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1900960781500819009607815008
09009607815001090096078150019009607815001

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hoodA non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.

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
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
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
19009607815008ViVi PEEL-OFF HOODTHI Total Healthcare Innovation GmbHFXY2025-06-10
07613327625172Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
07613327625189Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
07613327625233Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625173Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625180Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625234Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
09009607801004ViVi HelmetTHI Total Healthcare Innovation GmbHFXY2023-11-10
09009607801301ViVi Helmet HPLTHI Total Healthcare Innovation GmbHFXY2023-11-10
09009607812000ViVi HoodTHI Total Healthcare Innovation GmbHFXY2023-11-10
07613327465860T7STRYKER CORPORATIONFXY2020-05-11
07613327465884T7PlusSTRYKER CORPORATIONFXY2020-05-11
07613327465891T7PlusSTRYKER CORPORATIONFXY2020-05-11
07613327466683T7STRYKER CORPORATIONFXY2020-05-11
07613327466706T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327465861T7STRYKER CORPORATIONFXY2020-05-11
37613327465885T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327465892T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327466684T7STRYKER CORPORATIONFXY2020-05-11
37613327466707T7PlusSTRYKER CORPORATIONFXY2020-05-11
50192253018774CARDINAL HEALTHCardinal Health 200, LLCFXY2019-06-26
50192253018781CARDINAL HEALTHCardinal Health 200, LLCFXY2019-06-26
20885380019811CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
50885380019812CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
50630140927162CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
07613252661078Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
07613252661085Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661079Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661086Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23