AccessGUDID - DEVICE: Adjustable Flex Wide Belt Radiation Protection Apron-Pb Free-Large (00850035588406)

GUDID

Device Identifier (DI) Information

Brand Name: Adjustable Flex Wide Belt Radiation Protection Apron-Pb Free-Large
Version or Model: AFWB-PbF-LG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Barrier Technologies, LLC

Primary DI Number: 00850035588406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621134084 *Terms of Use

Device Description: The Adjustable Flex with Wide Belt radiation protection apron offers even weight distribution for less stress on the neck and back. 6” fully adjustable wide elastic belt shifts the weight of the apron from the shoulders to the hips. Fully adjustable back saver belt provides maximum support to the lower lumbar region. Velcro shoulder strap helps prevent slippage and shoulder pads provide additional comfort.

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?
38355	Radiation shielding apron	A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAJ	Apron, Leaded

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: 15ff77a8-c660-4f81-aa78-761b84b0ba6b
Public Version Date: October 14, 2022
Public Version Number: 1
DI Record Publish Date: October 06, 2022