FDA.reportPublic FDA data

LOLA

Primary DI
00850017666863
Brand
LOLA
Company
ALYK, INC.
Model
Washable Period Underwear Size Large
Published
2022-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NUQPad, Menstrual, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUQPad, Menstrual, ReusableObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017666863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017666863008500176668638500176668630850017666863

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual underwearA garment intended to be worn directly against the skin, in the same manner as conventional women's underwear, to absorb menstrual blood or other vaginal discharge. It is typically constructed of cotton, lycra and/or polyester with a leak-proof thermoplastic polyurethane (TPU) barrier. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079830975
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017666733LOLAMenstrual Cup Size Mini2021-05-17
00850017666405LOLAMenstrual Cup Size 12021-01-07
00850017666412LOLAMenstrual Cup Size 22021-01-07
00850017666269LOLAPersonal Lubricant2021-01-25
00850017666016LOLA24ct Ultra Thin Lubricated Condoms2020-06-30
00850017666788LOLAPregnancy Test2021-11-24
00850017666832LOLAWashable Period Underwear Size Extra Small2022-07-08
00850017666870LOLAWashable Period Underwear Size Extra Large2022-07-08
00850017666887LOLAWashable Period Underwear Size Extra Extra Large2022-07-08
00850017666849LOLAWashable Period Underwear Size Small2022-07-07
00850017666856LOLAWashable Period Underwear Size Medium2022-07-07
00850017666771LOLAOvulation Test2021-11-24
00850017666726LOLAThe Girl-On-The-Go Period Kit2021-04-21
00851617007223LOLA8 count light compact applicator organic cotton ta2020-02-20
00851617007230LOLA8 count regular compact applicator organic cotton 2020-02-20
00851617007247LOLA8 count super compact applicator organic cotton ta2020-02-20
00851617007254LOLA8 count super+ compact applicator organic cotton t2020-02-20
00851617007131LOLATrial Set2019-12-05
00851617007018LOLA100% organic cotton compact plastic applicator2019-06-17
00851617007025LOLA100% organic cotton non-applicator2019-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850063931042Everylife Inc.EDEN FEMININE CARE LLCNUQ2025-06-02
10850063931059Everylife Inc. EDEN FEMININE CARE LLCNUQ2025-05-27
00850063931076Everylife Inc. EDEN FEMININE CARE LLCNUQ2025-05-27
00841445000428Diva UnderwearDiva International IncNUQ2024-07-17
00841445000435Diva UnderwearDiva International IncNUQ2024-07-17
00841445000442Diva UnderwearDiva International IncNUQ2024-07-17
00841445000459Diva UnderwearDiva International IncNUQ2024-07-17
00841445000466DivaDiva International IncNUQ2023-09-29
00841445000473DivaDiva International IncNUQ2023-09-29
00841445000480DivaDiva International IncNUQ2023-09-29
00841445000497DivaDiva International IncNUQ2023-09-29
00850017666832LOLAALYK, INC.NUQ2022-07-08
00850017666870LOLAALYK, INC.NUQ2022-07-08
00850017666887LOLAALYK, INC.NUQ2022-07-08
00850017666849LOLAALYK, INC.NUQ2022-07-07
00850017666856LOLAALYK, INC.NUQ2022-07-07