AccessGUDID - DEVICE: Trojan HotSpot Vibrating Ring and 1 Ultra Thin Condom (00022600906674)

GUDID

Device Identifier (DI) Information

Brand Name: Trojan HotSpot Vibrating Ring and 1 Ultra Thin Condom
Version or Model: 00022600906674
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHURCH & DWIGHT CO., INC.

Primary DI Number: 00022600906674
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001211952 *Terms of Use

Device Description: One Trojan Hot Spot Vibrating Ring designed to provide spot on pleasure. 1 Trojan Ultra Thin Latex Condom for Contraception Plus STI Protection.

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):	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?
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 [?]
K901192	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
Special Storage Condition, Specify: For the Condom: Avoid exposure to direct sunlight or storage for prolonged periods at temperatures above 100 Degrees F.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de2fd260-2707-407b-9bc9-5615624fbd3a
Public Version Date: July 18, 2019
Public Version Number: 1
DI Record Publish Date: July 10, 2019