AccessGUDID - DEVICE: myONE B11 (00726893510135)

GUDID

Device Identifier (DI) Information

Brand Name: myONE B11
Version or Model: MYONE-B11-6
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GLOBAL PROTECTION CORP.

Primary DI Number: 00726893510135
Issuing Agency: GS1
Commercial Distribution End Date: January 08, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 364614362 *Terms of Use

Device Description: 6 Lubricated Male Latex Condoms

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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e675998-4d98-43d9-bd35-ff95b0fe14d1
Public Version Date: March 28, 2023
Public Version Number: 2
DI Record Publish Date: June 01, 2020