AccessGUDID - DEVICE: Probe Thick Rich lubricant

GUDID

Device Identifier (DI) Information

Brand Name: Probe Thick Rich lubricant - 2.5fl oz/75ml
Version or Model: 000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Davryan Laboratories, Inc.

Primary DI Number: B25004
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013204615 *Terms of Use

Device Description: Probe Thick Rich lubricant - 2.5fl oz/75ml

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
60412	Sexual lubricant	A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIS	Condom

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K952464	000

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: 0c9c3f4b-526b-4a13-97ed-6c03432a9847
Public Version Date: May 21, 2021
Public Version Number: 7
DI Record Publish Date: October 26, 2016