AccessGUDID - DEVICE: SHIELDED WASTE CONTAINER (00718175000113)

GUDID

Device Identifier (DI) Information

Brand Name: SHIELDED WASTE CONTAINER
Version or Model: 039-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 039-110
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175000113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: Waste Container, Shielded, .25" Lead

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":	No
For Single-Use:	No
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?
35430	Radioactive waste container	A hard-walled container designed for the safe deposit, collection and storage of radioactive materials including containers previously used for those materials (e.g., scintillation vials). It is made from metal and/or hard plastic and typically designed with an internal radiation shield [e.g., a lead (Pb) liner]. It typically has a lid with radiation shielding properties that allows temporary and final closure options. It is identified with a radioactive symbol on its labelling and sent to a radioactive waste treatment plant for disposal when filled to the recommended level.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPY	Shield, Protective, Personnel

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: 8c7392ff-2d58-4146-8562-f200793e529b
Public Version Date: August 18, 2023
Public Version Number: 2
DI Record Publish Date: May 31, 2019