AccessGUDID - DEVICE: Regard™ (00326053119132)

GUDID

Device Identifier (DI) Information

Brand Name: Regard™
Version or Model: CVRBTTIEL-REG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CVRBTTIEL-REG
Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Primary DI Number: 00326053119132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 134472476 *Terms of Use

Device Description: COVER BOOT FLD RST REGULAR LARGE FOM NON SKD CTD PP BLUE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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: 44501c20-2e91-47c2-bd13-0d4a4849be66
Public Version Date: November 23, 2022
Public Version Number: 1
DI Record Publish Date: November 15, 2022