FDA.report

Maosheng

Primary DI
06973635612013
Brand
Maosheng
Company
XianTao Maosheng Plastic Products Co., Ltd
Model
XL
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXOSuit, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXOSuit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06973635612013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973635612013069736356120136973635612013

GMDN Terms

TermDefinition
Visitor hygiene coverallA garment intended to be worn by a visitor, or staff, in a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. Also known as a jump suit, it is a one-piece suit (overall) with sleeves, trouser legs, and fasteners intended to be worn over existing clothing to provide a barrier to help prevent cross-contamination of infectious agents between visitor and patients. This is a single-use garment.

Sterilization Methods

Method

Regulatory Flags

DUNS number
543031224
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16
00850044799619SURGYCOSurgyco LLCFXO2023-02-16
00850044799626SURGYCOSurgyco LLCFXO2023-02-16
00850044799633SURGYCOSurgyco LLCFXO2023-02-16
00850044799640SURGYCOSurgyco LLCFXO2023-02-16
00850044799657SURGYCOSurgyco LLCFXO2023-02-16
00850044799664SURGYCOSurgyco LLCFXO2023-02-16
00850044799671SURGYCOSurgyco LLCFXO2023-02-16
00850044799688SURGYCOSurgyco LLCFXO2023-02-16
16975257180502TSWXiantao TSW Protective Products Co.,LtdFXO2023-02-16
00097604440127Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440226Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440325Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440424Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440523Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440622Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28