FDA.reportPublic FDA data

SF-3L Solofit AAMI III SMS Gown Large

Primary DI
00085415000703
Brand
SF-3L Solofit AAMI III SMS Gown Large
Company
OPERATING ROOM INNOVATIONS, INC.
Model
SF-3L
Catalog number
SF-3L
Published
2017-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00085415000703PackageGS136In Commercial Distribution
00854150007026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085415000703000854150007030854150007030085415000703
00854150007026008541500070268541500070260854150007026

GMDN Terms#

Term, Definition table
TermDefinition
Operating room gown, single-useA garment made of natural and/or synthetic materials intended to be worn over a scrub suit during a surgical procedure; it may be fluid resistant or impervious to fluids. An operating room (OR) gown 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7166810866rdean@exactmm.com

Regulatory Flags#

DUNS number
080246656
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854150007392Specialty Anterior Hip DrapeORI-SDL-DAHIPORI-SDL-DAHIP2026-01-01
00854150007408Specialty Lower Extremity DrapeORI-SDL-LEADORI-SDL-LEAD2026-01-01
00854150007422Universal Upper Extremity DrapeORI-SDL-UPXDORI-SDL-UPXD2026-01-01
06975085708605ORIORI-SDL-DAHIPORI-SDL-DAHIP2023-04-03
00850003355016ORISF-4XL-ELSF-4XL-EL2018-11-09
00850003355030ORISF-4XXL-ELSF-4XXL-EL2018-11-09
00854150007002SF-3PL Solofit AAMI III SMS Gown Poly Reinforced LargeSF-3PLSF-3PL2017-03-02
00854150007026SF-3L Solofit AAMI III SMS Gown LargeSF-3LSF-3L2017-03-02
00854150007040SF-3XL Solofit AAMI III SMS Gown X-LargeSF-3XLSF-3XL2017-03-02
00854150007064SF-3PXL Solofit AAMI III SMS Gown Poly Reinforced X-LargeSF-3PXLSF-3PXL2017-03-02
00854150007071SF-3XXL Solofit AAMI III SMS Gown XX-LargeSF-3XXLSF-3XXL2017-03-02
00854150007095SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-LargeSF-3PXXLSF-3PXXL2017-03-02
00854150007118DS-100 ORI Drop Stop KitDS-100DS-1002017-03-02
00854150007132ORI Self Donning Tabs KitSF-SDT-1SF-SDT-12017-08-01
00854150007156ORISF-4PLSF-4PL2017-10-24
00854150007163ORISF-4XLSF-4XL2017-10-24
00854150007187ORISF-4XXLSF-4XXL2017-10-24
00854150007231ORIUH-3UH-32019-01-07
00854150007248SoloFitSF-4XXXL-ELSF-4XXXL-EL2019-06-03
00854150007262ORIORI-SDL-LEADORI-SDL-LEAD2020-06-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
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09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
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10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
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08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
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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
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20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
00842942017223PRIMEDpriMED Medical Products IncFYA2025-07-15
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00842942017247PRIMEDpriMED Medical Products IncFYA2025-07-15
00842942017254PRIMEDpriMED Medical Products IncFYA2025-07-15
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