AccessGUDID - DEVICE: L.A.Confidential - Love Triangle (00850836007014)

GUDID

Device Identifier (DI) Information

Brand Name: L.A.Confidential - Love Triangle
Version or Model: LAC0001LT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CAUTION WEAR CORP

Primary DI Number: 00850836007014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177056145 *Terms of Use

Device Description: Male Latex Condom, Ribbed-Studded-Contoured, Regular Fit (53 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 100 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 798333ab-9073-45df-beb0-a23613117ae1
Public Version Date: June 18, 2021
Public Version Number: 3
DI Record Publish Date: October 11, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00850836007052	4000	00850836007014	In Commercial Distribution	Case
00850836007038	1000	00850836007014	In Commercial Distribution	Inner Pack
00850836007045	4	00850836007038	In Commercial Distribution	Case
00850836007649	24	00850836007014	In Commercial Distribution	Plastic Bag
00850836007656	50	00850836007014	In Commercial Distribution	Plastic Bag
00850836007663	100	00850836007014	In Commercial Distribution	Plastic Bag
00850836007670	200	00850836007014	In Commercial Distribution	Plastic Bag