FDA.reportPublic FDA data

Maddox Defense

Primary DI
10850038889002
Brand
Maddox Defense
Company
Maddox Defense Inc.
Model
MDSurg3-S
Device description
Surgical Gown, Small, AAMI Level 3
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10850038889002PackageGS140In Commercial Distribution
00850038889005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003888900210850038889002
00850038889005008500388890058500388890050850038889005

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969785539
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
true
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
00850038889111Maddox Defense ABDL2-L-US 2022-07-28
00850038889128Maddox Defense ABDL2-XL-US 2022-07-28
00850038889135Maddox DefenseABDL2-99L-US 2022-07-28
00850038889142Maddox Defense ABDL2-99XL-US 2022-07-28
10850038889118Maddox Defense / MACS ABDL2-L-US 2022-07-28
10850038889125Maddox Defense / MACS ABDL2-XL-US 2022-07-28
10850038889132Maddox Defense / MACS ABDL2-99L-US 2022-07-28
10850038889149Maddox Defense / MACS ABDL2-99XL-US 2022-07-28
00850038889005Maddox DefenseMDSurg3-S 2022-03-14
00850038889012Maddox DefenseMDSurg3-M2022-03-14
00850038889029Maddox DefenseMDSurg3-L2022-03-14
00850038889036Maddox DefenseMDSurg3-XL2022-03-14
00850038889043Maddox DefenseMDSurg3-XXL2022-03-14
00850038889050Maddox DefenseMDSurg4-S2022-03-14
00850038889067Maddox DefenseMDSurg4-M2022-03-14
00850038889074Maddox DefenseMDSurg4-L2022-03-14
00850038889081Maddox DefenseMDSurg4-XL2022-03-14
00850038889098Maddox DefenseMDSurg4-XXL2022-03-14
10850038889019Maddox DefenseMDSurg3-M2022-03-14
10850038889026Maddox DefenseMDSurg3-L2022-03-14

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
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
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