AccessGUDID - DEVICE: Trojan™ Premium Latex Condoms BareSkin™ Value Pack (00022600998532)

GUDID

Device Identifier (DI) Information

Brand Name: Trojan™ Premium Latex Condoms BareSkin™ Value Pack
Version or Model: 00022600998532
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHURCH & DWIGHT CO., INC.

Primary DI Number: 00022600998532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 001211952 *Terms of Use

Device Description: No description.

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:	Yes
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

[?]

Product Code	Product Code Name
HIS	CONDOM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090259	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1092c27-40ba-4ebc-83f4-3d7867d88fa0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 14, 2016