FDA.reportPublic FDA data

Steri-Shield

Primary DI
07613327625271
Brand
Steri-Shield
Company
STRYKER CORPORATION
Model
0424751200
Catalog number
0424-751-200
Device description
8 Pullover Toga with Anti-Reflective Face Shield
Published
2025-02-21
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
37613327625272PackageGS19In Commercial Distribution
07613327625271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332762527237613327625272
07613327625271076133276252717613327625271

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
+0018002533210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
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
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
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

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
09009607822207ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
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
07613327625196Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625219Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625226Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625240Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625257Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625264Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625288Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625295Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625301Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625318Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625325Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625332Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21