FDA.reportPublic FDA data

Disposable Full Bodysuit

Primary DI
08936064200006
Brand
Disposable Full Bodysuit
Company
TNG INVESTMENT AND TRADING JOINT STOCK COMPANY
Model
Y0242
Device description
The body included: hood, jumpsuit & shoe coverWater repellency, full cover, front zipper, elastic cuff,disposable
Published
2020-08-13
Public version status
New
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
FXOSuit, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXOSuit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936064200006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936064200006089360642000068936064200006

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
555325484
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08936064200013Disposable Isolation GownY01402020-08-13
08936064200020Disposable Isolation GownY01462020-08-13
08936064200037Disposable Full Bodysuit & AccessoriesY03662020-08-13
08936064200150DISPOSABLE MEDICAL MASKY03842020-08-13
08936064200167Disposable Boot CoverMDC-PS132020-08-13
08936064200174Disposable Medical CapMDCPH012020-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604599921Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2025-09-10
00889813060179Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060186Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060193Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060176Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060183Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060190Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
06921340881118customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340882115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340883112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340884119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340885116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340881115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340882112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340883119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340884116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340885113customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
10850044799593SURGYCOSurgyco LLCFXO2023-02-16
10850044799609SURGYCOSurgyco LLCFXO2023-02-16
10850044799616SURGYCOSurgyco LLCFXO2023-02-16
10850044799623SURGYCOSurgyco LLCFXO2023-02-16
10850044799630SURGYCOSurgyco LLCFXO2023-02-16
10850044799647SURGYCOSurgyco LLCFXO2023-02-16
10850044799654SURGYCOSurgyco LLCFXO2023-02-16
10850044799661SURGYCOSurgyco LLCFXO2023-02-16
10850044799678SURGYCOSurgyco LLCFXO2023-02-16
10850044799685SURGYCOSurgyco LLCFXO2023-02-16
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16