AccessGUDID - DEVICE: Ultra Thin Condom Sampler, (00726893112902)

GUDID

Device Identifier (DI) Information

Brand Name: Ultra Thin Condom Sampler,
Version or Model: BSC04096
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBAL PROTECTION CORP.

Primary DI Number: 00726893112902
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 96
Labeler D-U-N-S® Number*: 364614362 *Terms of Use

Device Description: Ultra Thin Condom Sampler- The list of lubricated condoms included in the sampler- One Vanish, Atlas ultra thin, Lifestyles ultra thin, Crown, Black Ice Ultra Thin, One Ultra feel, One Flex, Custom NYC One Vanish.

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
Special Storage Condition, Specify: Store at room temperature in a dark, dry place. Avoid excessive heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7f29b3b4-e8b6-4c77-b398-ee760b20a33f
Public Version Date: April 16, 2024
Public Version Number: 1
DI Record Publish Date: April 08, 2024