FDA.report

LEONA

Primary DI
08809599750097
Brand
LEONA
Company
LOON LAB INC.
Model
LEONA AIR FLOW SMALL
Device description
A menstrual cup is a feminine hygiene product that collects the menstrual fluid during menstruation. This DI has been created for use at Amazon.
Published
2019-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HHECup, Menstrual

Product Code Classifications

CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809599750097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809599750097088095997500978809599750097

GMDN Terms

TermDefinition
Menstrual cup, non-latex, reusableA cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
694613996
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809599750011LEONAAIR FLOW LARGE2018-03-14
08809599750028LEONAAIR FLOW SMALL2018-03-14
08809599750103LEONALEONA AIR FLOW LARGE2019-09-27
08809599750073LEONALEONA SPILL-FREE CAP SMALL2019-06-21
08809599750080LEONALEONA SPILL-FREE CAP LARGE2019-06-21
08809599750059LEONALEONA BASIC SMALL2019-06-20
08809599750066LEONALEONA BASIC LARGE2019-06-20

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