FDA.reportPublic FDA data

FRED'S SUPER DOLLAR

Primary DI
00084579128570
Brand
FRED'S SUPER DOLLAR
Company
FRED'S, INC.
Model
268496
Device description
FRD-024-4OZ LUB JELLY 4OZ
Published
2016-09-30
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
K070623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070623000PHARMAPAC LUBRICATING JELLYPharmapac, LLC2007-08-31NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00084579128570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00084579128570000845791285700845791285700084579128570

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003747417JSTREET@FREDSINC.COM

Regulatory Flags#

DUNS number
005866116
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00084579122424FRED'S TAMPONS FR12006F/22016-09-13
00084579122431FRED'S TAMPONS FR22006F/22016-09-13
00084579122455FRED'S TAMPONS FR11806UO2016-09-13
00084579122462FRED'S TAMPONS FR21806UO/22016-09-13
00084579122479FRED'S TAMPONS FR11806SO2016-09-13
00084579122486FRED'S TAMPONS FR21806S0/22016-09-13
00084579123032FRED'S TAMPONS FR32006F/22016-09-13
10084579122421FRED'S TAMPONS FR12006F/22016-09-13
10084579122438FRED'S TAMPONS FR22006F/22016-09-13
10084579122452FRED'S TAMPONS FR11806UO2016-09-13
10084579122469FRED'S TAMPONS FR21806UO/22016-09-13
10084579122476FRED'S TAMPONS FR11806SO2016-09-13
10084579122483FRED'S TAMPONS FR21806S0/22016-09-13
10084579123039FRED'S TAMPONS FR32006F/22016-09-13
00761059407577Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00084579128587FRED'S SUPER DOLLAR6371492016-09-30
00761059307570Fred's Unifine Pentips Plus - Short 8mmx31GAN 3830FRDAN 3830FRD2016-09-19
00761059842576Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00761059507574Fred's Unifine Pentips Plus - Mini 5mmx31GAN 3850FRDAN 3850FRD2016-09-19
00084579118625Fred's Pharmacy118622016-09-16

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