Tronex International, Inc.

GUDID 00097604945257

Gown, Isolation, Multilayer, AAMI Level 3, Tape-Tab Neck , Elastic Cuffs, Fluid Resistant, Latex-Free, Yellow, Unisize

TRONEX INTERNATIONAL, INC.

Isolation gown, single-use
Primary Device ID00097604945257
NIH Device Record Keyab1aa25b-c950-4e8b-aef8-2ef3c9d73614
Commercial Distribution StatusIn Commercial Distribution
Brand NameTronex International, Inc.
Version Model NumberMLN94525Y
Company DUNS615425519
Company NameTRONEX INTERNATIONAL, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com
Phone973-335-2888
Emailtronexproductmanagement@tronexcompany.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100097604945257 [Unit of Use]
GS110097604945254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYCGown, Isolation, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-18
Device Publish Date2023-04-10

On-Brand Devices [Tronex International, Inc.]

10097604925843Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604925836Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604925829Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604925812Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604924648Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604924631Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604924624Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604924617Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
10097604917749Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Extra-Large
10097604917732Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Large
10097604917725Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Medium
10097604917718Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Small
10097604913345Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Extra-Large
10097604913338Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Large
10097604913321Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Medium
10097604913314Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Small
00097604983051Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
00097604983044Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
00097604983037Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
00097604983020Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
00097604983013Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
00097604983006Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
00097604977050Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
00097604977043Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
00097604977036Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
00097604977029Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
00097604977012Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
00097604977005Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
00097604967242Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Extra-Large
00097604967235Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Large
00097604967228Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Medium
00097604967211Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Small
00097604967204Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Extra-Small
00097604966252Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
00097604966245Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
00097604966238Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
00097604966221Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
00097604966214Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
00097604966207Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
00097604939447Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
00097604939430Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Lar
00097604939423Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Med
00097604939416Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Sma
00097604939409Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
00097604939348Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
00097604939331Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Lar
00097604939324Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Med
00097604939317Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Sma
00097604939300Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
00097604925259Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Blue, 2X-Large

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.