FDA.report

Tronex International, Inc.

Primary DI
00097604440424
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
SMS44035B
Device description
Scrub, Shirt, Multilayer, W/ Pockets, V-Neck, Fluid Resistant, Latex-Free, Blue, Extra-Large
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10097604440421PrimaryGS10
00097604440424Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760444042110097604440421
00097604440424000976044404240976044404240097604440424

GMDN Terms

TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Sterilization Methods

Method

Regulatory Flags

DUNS number
615425519
Device count
50
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
false
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 From This Company

Primary DIBrandModelCatalogPublished
00097604555517Tronex International, Inc.5555W2025-07-28
00097604577021Tronex International, Inc.577025W2025-07-24
00097604577045Tronex International, Inc.577035W2025-07-24
00097604130585Tronex International, Inc.TCB0305C2025-05-01
00097604140584Tronex International, Inc.TCB0405C2025-05-01
00097604160582Tronex International, Inc.TCB0605C2025-05-01
00097604220583Tronex International, Inc.TLB2205L2025-05-01
00097604330589Tronex International, Inc.TLB3305L2025-05-01
00097604440585Tronex International, Inc.TLB4405L2025-05-01
00097604660587Tronex International, Inc.TLB6605L2025-05-01
00097604015561Tronex International, Inc.TCB0155R2025-01-28
00097604010580Tronex International, Inc.TCB0105C2024-12-30
00097604020589Tronex International, Inc.TCB0205C2024-12-30
00097604110587Tronex International, Inc.TCB1105A2024-12-30
00097604120586Tronex International, Inc.TCB1205A2024-12-30
00097604212199Tronex International, Inc.SD21212024-12-30
00097604215190Tronex International, Inc.SD21512024-12-30
00097604313193Tronex International, Inc.SD31312024-12-30
00097604422291Tronex International, Inc.TCB4222N2024-12-30
00097604423397Tronex International, Inc.TCB4233N2024-12-30

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
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
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
00097604440523Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440622Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28