AccessGUDID - DEVICE: CautionWear L.A.Confidential

GUDID

Device Identifier (DI) Information

Brand Name: CautionWear L.A.Confidential - Dark Desire
Version or Model: LAC0001DD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CAUTION WEAR CORP

Primary DI Number: 00850836007113
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, Contoured, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Tip, Lubricated With Ultra-Smooth Silicon-Based Lubricant

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: edc8f934-e7b3-4991-8976-01e200555cad
Public Version Date: June 29, 2021
Public Version Number: 1
DI Record Publish Date: June 21, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00850836007762	24	00850836007113	In Commercial Distribution	Plastic Bag
00850836007779	50	00850836007113	In Commercial Distribution	Plastic Bag
00850836007786	100	00850836007113	In Commercial Distribution	Plastic Bag
00850836007793	200	00850836007113	In Commercial Distribution	Plastic Bag