FDA.report

ROSE

Primary DI
07290019338086
Brand
ROSE
Company
ORGENICA O.A.A LTD
Model
Non-applicator, Super
Device description
Non-Applicator Organic Cotton Cottonlock Tampons, Super, 18u
Published
2022-09-26
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
true

Related Records

Product Codes

CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications

CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290019338086PackageGS124In Commercial Distribution
07290019338017PrimaryGS10
08432984002817Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290019338086072900193380867290019338086
07290019338017072900193380177290019338017
08432984002817084329840028178432984002817

GMDN Terms

TermDefinition
Menstrual tampon, unscentedA non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
600767519
Device count
18
DM exempt
false
Premarket exempt
false
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
07290019338079ROSENon-applicator2022-09-26
07290019338093ROSECardboard applicator, Regular2022-09-26
07290019338109ROSECardboard applicator, Super2022-09-26

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