AccessGUDID - DEVICE: Tronex International, Inc. (10097604490259)

GUDID

Device Identifier (DI) Information

Brand Name: Tronex International, Inc.
Version or Model: 49025B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRONEX INTERNATIONAL, INC.

Primary DI Number: 10097604490259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 120
Labeler D-U-N-S® Number*: 615425519 *Terms of Use

Device Description: Cover, Boot, PE Coated Multilayer, Heavy-Weight Knee-High, Ties, Foam Strip Non-Skid Tread, Fluid Impervious, Latex-Free, Blue, Unisize

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXP	Cover, Shoe, Operating-Room

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 10542ad6-8efe-4c3e-93ef-8efaec759fc9
Public Version Date: November 07, 2022
Public Version Number: 1
DI Record Publish Date: October 28, 2022