Good Sense

Primary DI
00070030147655
Brand
Good Sense
Company
L PERRIGO COMPANY
Model
7W926C2C1
Device description
Lubricating Jelly4oz. (113g)
Published
2022-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K012203000
K180923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012203000CLAY-PARK LABS, INC. - LUBRICATING JELLYClay-Park Labs, Inc.2001-08-27NUC
K180923000Personal Lubricating JellyPerrigo New York, Inc.2018-07-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20070030147659PackageGS16In Commercial Distribution
30070030147656PackageGS124In Commercial Distribution
50070030147650PackageGS124In Commercial Distribution
00070030147655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007003014765920070030147659
3007003014765630070030147656
5007003014765050070030147650
00070030147655000700301476550700301476550070030147655

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006013346
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070030511739SCARAWAY SILICONE GEL 20G11A3QSAC12021-03-17
00070030165536SCARAWAY SILICONE GEL 20G11A3QSAC12021-03-17
00070030510718Comfort Assist Insulin Syringe1030082016-09-24
00070030510725Comfort Assist Insulin Syringe0331082016-09-24
00070030510732Comfort Assist Insulin Syringe0531082016-09-24
00070030510749Comfort Assist Insulin Syringe1029122016-09-24
00070030510756Comfort Assist Insulin Syringe0330082016-09-24
00070030510763Comfort Assist Insulin Syringe0530082016-09-24
00070030510770Comfort Assist Insulin Syringe1031082016-09-24
00370030128709GoodSense Comfort Assist Insulin Syringes0529122016-09-24
00370030128716GoodSense Comfort Assist Insulin Syringes1030082016-09-24
00370030128723GoodSense Comfort Assist Insulin Syringes0331082016-09-24
00370030128730GoodSense Comfort Assist Insulin Syringes0531082016-09-24
00370030128747GoodSense Comfort Assist Insulin Syringes0330082016-09-24
00370030128754GoodSense Comfort Assist Insulin Syringes0530082016-09-24
00370030128761GoodSense Comfort Assist Insulin Syringes1031082016-09-24
10370030128706GoodSense Comfort Assist Insulin Syringes0529122016-09-24
10370030128713GoodSense Comfort Assist Insulin Syringes1030082016-09-24
10370030128720GoodSense Comfort Assist Insulin Syringes0331082016-09-24
10370030128737GoodSense Comfort Assist Insulin Syringes0531082016-09-24

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