FDA.reportPublic FDA data

Sasmar Pina Colada

Primary DI
09337213008167
Brand
Sasmar Pina Colada
Company
Sasmar Pharmaceuticals SPRL
Model
50ml
Catalog number
880816
Device description
PERSONAL LUBRICANT
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131084000SASMAR ORIGINAL, SASMAR CLASSICSasmar, Inc.2013-09-13NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19337213008164PackageGS16In Commercial Distribution
29337213008161PackageGS18In Commercial Distribution
09337213008167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933721300816419337213008164
2933721300816129337213008161
09337213008167093372130081679337213008167

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, non-sterileA non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
773 942-0030helpdesk@sasmar.com

Regulatory Flags#

DUNS number
370696875
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09337213008143Sasmar Classic50ml8808142016-10-03
09337213008150Sasmar Warming50ml8808152016-10-03
09337213008174Sasmar Strawberry50ml8808172016-10-03
09337213008181Sasmar Original60ml8808182016-10-03
09337213008198Sasmar Cherry50ml8808192016-10-03
09337213008204Sasmar Vanilla50ml8808202016-10-03
09337213008211Sasmar Classic60ml8808212016-10-03
09337213008228Sasmar Warming60ml8808222016-10-03
09337213008235Sasmar Pina Colada60ml8808232016-10-03
09337213008242Sasmar Strawberry60ml8808242016-10-03
09337213008259Sasmar Cherry60ml8808252016-10-03
09337213008266Sasmar Vanilla60mlK1310842016-10-03
09337213008303Sasmar Melon60ml8808302016-10-03
09337213008310Sasmar Melon50ml8808312016-10-03
09337213008419Conceive Plus30ml8808412016-10-03
09337213008426Conceive Plus75ml8808422016-10-03
09337213008457Conceive Plus8x4g8808452016-10-03
09337213008464Conceive Plus3x4g8808462016-10-03
09337213008549Sasmar Classic118ml8808542016-10-03

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