Rael Organic Cotton Tampons: Regular Absorbancy

GUDID 00856032008442

A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.

RAEL INC

Menstrual tampon, unscented
Primary Device ID00856032008442
NIH Device Record Key95fe24ff-2efa-4fc6-9a4b-82418314a26f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRael Organic Cotton Tampons: Regular Absorbancy
Version Model NumberRAEL-TP-RG-01
Company DUNS087378348
Company NameRAEL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856032008442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEBTampon, Menstrual, Unscented

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-28
Device Publish Date2019-08-20

Devices Manufactured by RAEL INC

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00810027131621 - Rael2023-04-03
00810027131614 - Rael2023-03-30
00856032008442 - Rael Organic Cotton Tampons: Regular Absorbancy2019-08-28A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
00856032008442 - Rael Organic Cotton Tampons: Regular Absorbancy2019-08-28 A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an appli
00856032008947 - RAEL 2019-05-27 Organic cotton cardboard applicator tampons, regular absorbency. Distributed in bulk.

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