AccessGUDID - DEVICE: Union (00054003788588)

GUDID

Device Identifier (DI) Information

Brand Name: Union
Version or Model: Union Latex Condoms MAX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11402
Company Name: MAYER LABORATORIES, INC.

Primary DI Number: 00054003788588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 175425982 *Terms of Use

Device Description: Latex Condoms 144 ct

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?
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIS	CONDOM

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 40 and 90 Degrees Fahrenheit
Special Storage Condition, Specify: NO DIRECT SUNLIGHT OR HEAT

Clinically Relevant Size

[?]

Size Type Text
Length: 160 Millimeter
Width: 60 Millimeter

Device Record Status

Public Device Record Key: 9f8d2bac-ea96-49af-b5bb-19d18575447f
Public Version Date: November 14, 2023
Public Version Number: 1
DI Record Publish Date: November 06, 2023