FDA.reportPublic FDA data

Probe Thick Rich lubricant - .33fl oz/10ml

Primary DI
B25002
Brand
Probe Thick Rich lubricant - .33fl oz/10ml
Company
Davryan Laboratories, Inc.
Model
000
Device description
Probe Thick Rich lubricant - .33fl oz/10ml
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952464000PROBE PERSONAL LUBRICANT - CLASSICDavryan Laboratories, Inc.1995-11-22HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B25092PackageHIBCC50In Commercial Distribution
B25002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA non-sterile 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. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
503-235-8480scott@davryan.com
800-637-7623ken@davryanlabs.com

Regulatory Flags#

DUNS number
013204615
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B25001Probe Silky Light lubricant - .33fl oz/10ml0002016-10-26
B25003Probe Silky Light lubricant - 2.5fl oz/75ml0002016-10-26
B25004Probe Thick Rich lubricant - 2.5fl oz/75ml0002016-10-26
B25005Probe Silky Light lubricant - 8.5fl oz/250ml0002016-10-26
B25006Probe Thick Rich lubricant - 8.5fl oz/250ml0002016-10-26
B25007Probe Silky Light lubricant - 17fl oz/500ml0002016-10-26
B25008Probe Thick Rich lubricant - 17fl oz/500ml0002016-10-26

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