FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50630140927162
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
4381
Catalog number
4381
Device description
HOOD AND BEARD COVER
Published
2018-12-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
50630140927162PrimaryGS10
10630140927164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5063014092716250630140927162
1063014092716410630140927164

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09009607815001ViVi PEEL-OFF HOODTHI Total Healthcare Innovation GmbHFXY2025-06-10
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
07613252661078Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
07613252661085Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661079Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661086Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23