FDA.reportPublic FDA data

NA

Primary DI
00849296007399
Brand
NA
Company
WELMED INC.
Model
1231-173L
Published
2017-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070431000WELMED, INC. SURGICAL GOWNSWelmed, Inc.2007-05-24FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849296007396PackageGS124In Commercial Distribution
00849296007399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084929600739610849296007396
00849296007399008492960073998492960073990849296007399

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
Ethylene Oxide

Regulatory Flags#

DUNS number
828213426
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849296017107Welmed, Inc.IOT-CDS122026-03-26
00849296004916Welmed, Inc.1222-86522026-03-20
00849296002790Welmed, Inc.1222-86662017-06-14
00849296003353Welmed, Inc.1501-10182017-06-14
00849296013345Welmed1300-01TB2026-02-15
00849296013352Welmed1300-02LL2026-02-15
00849296013369Welmed1300-03LL2026-02-15
00849296013376Welmed1300-03LS2026-02-15
00849296013383Welmed1300-05LL2026-02-15
00849296013390Welmed1300-05LS2026-02-15
00849296013406Welmed1300-06LL2026-02-15
00849296013413Welmed1300-10CNTL2026-02-15
00849296013420Welmed1300-10LL-8002026-02-15
00849296013437Welmed1300-10LS2026-02-15
00849296013444Welmed1300-12LL2026-02-15
00849296013451Welmed1300-20LL2026-02-15
00849296013475Welmed1300-30LL2026-02-15
00849296013482Welmed1300-30LS2026-02-15
00849296013499Welmed1300-60LL2026-02-15
00849296013505Welmed1300-60LS2026-02-15

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
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