AccessGUDID - DEVICE: Zero Gravity (00618125176076)

GUDID

Device Identifier (DI) Information

Brand Name: Zero Gravity
Version or Model: ZGAV-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZGAV-M
Company Name: TIDI PRODUCTS, LLC

Primary DI Number: 00618125176076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063519193 *Terms of Use

Device Description: Medium Vest; Accessory Intended for Use with Zero Gravity Radiation Protection System

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):	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?
38373	Radiation shielding panel, portable/mobile	A portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].	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: b210540a-fb22-466e-b92e-d6a90d8a0ef9
Public Version Date: October 14, 2022
Public Version Number: 1
DI Record Publish Date: October 06, 2022