FDA.reportPublic FDA data

SRI Healthcare

Primary DI
00850057346312
Brand
SRI Healthcare
Company
Elevate Textiles, Inc.
Model
PREMSRGWNXLT-03-SV-0MDGN-2XL
Catalog number
7405
Device description
Surgical Gown, Level 3, Size 2XL, Green, Reuseable
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00850057346312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057346312008500573463128500573463120850057346312

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, reusableA 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 reusable garment intended to be laundered after each use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
13366841683nathaniel.terry@elevatetextiles.com

Regulatory Flags#

DUNS number
825198484
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057346015SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-0SM74012024-04-08
00850057346022SRI HealthcareWRAP03603600-4-SV-0MDGN-043002024-04-08
00850057346039SRI HealthcareWRAP04804800-4-SV-0MDGN-043502024-04-08
00850057346046SRI HealthcareWRAP05405400-4-SV-0MDGN-043542024-04-08
00850057346053SRI HealthcareWRAP05307200-4-SV-0MDGN-043602024-04-08
00850057346237SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0SM78012024-04-08
00850057346244SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-0MD78022024-04-08
00850057346251SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-0LG78032024-04-08
00850057346268SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-0XL78042024-04-08
00850057346275SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-2XL78052024-04-08
00850057346282SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-0MD74022024-04-08
00850057346305SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-0XL74042024-04-08
00850057346336SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0MD70022024-04-08
00850057346343SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0LG70032024-04-08
00850057346350SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0XL70042024-04-08
00850057346367SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-2XL70052024-04-08
00850057346381Burlington IndustriesSURGWNMAXULT03-SV-0115F-0MD79022024-04-08
00850057346411Burlington IndustriesSURGWNMAXULT03-SV-0115F-2XL79052024-04-08
00850057346091SRI HealthcareDRAPE0721050-4-SV-0MDGN-00030462024-04-05
00850057346145SRI HealthcareSHEET0540720-4-SV-0MDGN-00038732024-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
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
07613327625271Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625288Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625295Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625301Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625318Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21