AccessGUDID - DEVICE: Radians (00674326398624)

GUDID

Device Identifier (DI) Information

Brand Name: Radians
Version or Model: RWG9115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RWG9115L
Company Name: Radians, Inc.

Primary DI Number: 00674326398624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 044600976 *Terms of Use

Device Description: Powder Free Latex Examination Gloves, Cream, Non-Sterile. 5 Mil. Textured Grip. Single Use. Size Large.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
47172	Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial	A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYY	Latex Patient Examination Glove

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Shield gloves from direct sunlight, fluorescent light, x-rays, moisture, and ozone.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large
Width: 105 Millimeter

Device Record Status

Public Device Record Key: 65af6ee8-83dd-4ec6-94d4-899808afa16c
Public Version Date: January 30, 2025
Public Version Number: 1
DI Record Publish Date: January 22, 2025