AccessGUDID - DEVICE: Caliber (00860011454823)

GUDID

Device Identifier (DI) Information

Brand Name: Caliber
Version or Model: 311292520
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Caliber Brand LLC

Primary DI Number: 00860011454823
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 061265830 *Terms of Use

Device Description: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricated, sterile, single-use, over-the-counter device.

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 [?]
K210208	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 185 Millimeter
Width: 57 Millimeter

Device Record Status

Public Device Record Key: 8becbac8-c955-45fb-b1a2-361ad1be3373
Public Version Date: April 10, 2025
Public Version Number: 2
DI Record Publish Date: March 26, 2025