FDA.reportPublic FDA data

SOLOMED Disposable Surgical Gown

Primary DI
07502286510059
Brand
SOLOMED Disposable Surgical Gown
Company
Solomed, S.A. de C.V.
Model
Large Size
Device description
Disposable surgical gown with adjustable sleeves and cuffs, and chest gusset
Published
2020-07-17
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17502286510056PackageGS1100In Commercial Distribution
07502286510059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1750228651005617502286510056
07502286510059075022865100597502286510059

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
588625921
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07500463968341Sterilex1000ml2019-05-30
07500463968396FlexmarSmall2019-07-26
07502286510004FlexmarLarge2019-07-26
07502286510011Hidroderm 10 x 10 cm2019-07-26
07502286510028Hidroderm 15 x 16 cm2019-07-26
07502286510035Hidroderm 15 x 21 cm2019-07-26
07502286510042SOLOMED Disposable Surgical GownMedium Size 2020-07-17
07502286510066SOLOMED Disposable Surgical GownExtra Large Size2020-07-17
17502286510049Bata quirúrgica SOLOMEDTalla mediana2020-07-17
17502286510056Bata quirúrgica SOLOMEDTalla grande2020-07-17
17502286510063Bata quirúrgica SOLOMEDTalla extra grande2020-07-17
07500463968372Pleura Med Adult2019-05-30
07500463968389Pleura MedPediatric 2019-05-30
07500463968303Osto System Adult2019-05-30
07500463968310Osto SystemPediatric 2019-05-30
07500463968327Osto SystemNeonatal 2019-05-30
07500463968334Osto System Adult2019-05-30
07500463968358Bantex6cm2019-06-06
07500463968365Bantex8cm2019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344158895MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158918MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158932MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158956MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158970MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158987MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159014MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159106MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196247616MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196730248MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24