ROSE

Primary DI
07290019338109
Brand
ROSE
Company
ORGENICA O.A.A LTD
Model
Cardboard applicator, Super
Device description
Organic Cotton Cardboard Applicator Tampons, Super, 14u
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

Product Codes#

Code, Name table
CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019338109PackageGS112In Commercial Distribution
07290019338031PrimaryGS10
08432984001315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019338109072900193381097290019338109
07290019338031072900193380317290019338031
08432984001315084329840013158432984001315

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
600767519
Device count
14
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019338079ROSENon-applicator2022-09-26
07290019338086ROSENon-applicator, Super2022-09-26
07290019338093ROSECardboard applicator, Regular2022-09-26

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00850068130900Pixie CupPixie Cup LLCHEB2026-03-19
00850068130917Pixie CupPixie Cup LLCHEB2026-03-19
00850068130924Pixie CupPixie Cup LLCHEB2026-03-19
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00850068130948Pixie CupPixie Cup LLCHEB2026-03-19
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00990498500222Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704066Iris + ArloIris + Arlo Inc.HEB2026-01-05
00628942539299Iris + ArloIris + Arlo Inc.HEB2026-01-05
10050428273484CVS Health TamponsWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHEB2025-12-31
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