AccessGUDID - DEVICE: ADULT APRON BIB with COLLAR .3MM, Beige (00812045038364)

GUDID

Device Identifier (DI) Information

Brand Name: ADULT APRON BIB with COLLAR .3MM, Beige
Version or Model: 75051-23
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flow X Ray Corporation

Primary DI Number: 00812045038364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010016319 *Terms of Use

Device Description: ADULT APRON BIB with COLLAR .3MM, Beige 24" X 26"

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?
64135	Patient radiation shielding pad/drape, reusable	A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers.. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWO	Apron, Protective

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: 846ad77f-35c0-4bc4-a67c-a0643cc36416
Public Version Date: June 28, 2023
Public Version Number: 3
DI Record Publish Date: March 20, 2020