AccessGUDID - DEVICE: AMD-RITMED (20686864054898)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: A8008-PLAS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A8008-PLAS
Company Name: AMD Medicom Inc

Primary DI Number: 20686864054898
Issuing Agency: GS1
Commercial Distribution End Date: July 26, 2023
Device Count: 500
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED PLASTIC SHOE COVER Regular

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
Special Storage Condition, Specify: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Regular

Device Record Status

Public Device Record Key: 025679bd-9c55-4f77-8d21-fa7bfcd7ce1a
Public Version Date: July 27, 2023
Public Version Number: 3
DI Record Publish Date: January 24, 2019