FDA.reportPublic FDA data

CONVERTORS

Primary DI
10192253005943
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
9070
Catalog number
9070
Device description
Poly-Reinforced Surgical Gown, 2XL
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

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
50192253005941PackageGS118In Commercial Distribution
10192253005943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300594150192253005941
1019225300594310192253005943

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.

Regulatory Flags#

DUNS number
961027315
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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

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00627755521002Lac-MacLac-Mac LimitedFYA2026-10-13
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
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16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
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16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbHFYA2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
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16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
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