FDA.reportPublic FDA data

Pharmaceutical Innovations

Primary DI
00300361500202
Brand
Pharmaceutical Innovations
Company
PHARMACEUTICAL INNOVATIONS INC
Model
Gentle Gel Lubricating Gel
Catalog number
36-1500-20
Device description
Gentle Gel Lubricating Gel- 20 ml sterile packet
Published
2017-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMSLubricant, Vaginal, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMSLubricant, Vaginal, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10300361500209PackageGS125In Commercial Distribution
00300361500202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030036150020910300361500209
00300361500202003003615002023003615002020300361500202

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, sterileA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-242-2700info@pharminnovations.com

Regulatory Flags#

DUNS number
067486548
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300361000047Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-042016-09-20
00300361000122Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-25B2016-09-14
00300361000252Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-252016-09-14
00300361000603Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-602016-09-20
00300361000900Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-902016-09-14
00300361004052Pharmaceutical InnovationsVetGel Veterinary Ultrasound Gel36-1004-052016-09-20
00300361200607Pharmaceutical InnovationsUltraPhonic FREE Conductivity Gel36-1200-602016-09-14
00300361300154Pharmaceutical InnovationsUltraPhonic Focus Gel Pad36-1300-152016-09-14
00300361300253Pharmaceutical InnovationsUltraPhonic Focus Gel Pad36-1300-252016-09-14
00300361305029Pharmaceutical InnovationsUltraPhonic Focus Thin Gel Pad36-1305-022018-07-10
00300361600056Pharmaceutical InnovationsPhoton Transmitting Gel36-1600-052016-09-21
00300361000054Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-052016-09-20
00300361001044Pharmaceutical InnovationsUltraPhonic Scanning Gel36-1001-042016-09-20
00300361001051Pharmaceutical InnovationsUltraPhonic Scanning Gel36-1001-052016-09-20
00300361001259Pharmaceutical InnovationsUltraPhonic Scanning Gel 36-1001-252016-09-14
00300361001907Pharmaceutical InnovationsUltraPhonic Scanning Gel36-1001-902016-09-14
00300361111057Pharmaceutical InnovationsOther-Sonic High Viscosity Generic Ultrasound Gel36-1111-052016-09-21
00300361111255Pharmaceutical InnovationsOther-Sonic High Viscosity Generic Ultrasound Gel36-1111-252016-09-14
00300361111606Pharmaceutical InnovationsOther-Sonic High Viscosity Generic Ultrasound Gel36-1111-602016-09-14
00300361150049Pharmaceutical InnovationsGAMMA Massage & Ultrasound Gel36-1150-042016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00015594012148Astroglide Gel Personal LubricantBIOFILM, INCMMS2024-08-21
00716222203661WET Light Liquid LubricantTrigg Laboratories, Inc.MMS2019-03-18
00716222203715WET Light Liquid LubricantTrigg Laboratories, Inc.MMS2019-03-18
00716222203722WET Light Liquid LubricantTrigg Laboratories, Inc.MMS2019-03-18
00716222251006WET Light Liquid LubricantTrigg Laboratories, Inc.MMS2017-01-19
00300361500158Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCMMS2016-09-14
00300361500905Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCMMS2016-09-14