RAEL INC

Address:6940 Beach Blvd. D-301,Buena Park,CA,90621,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tampon, Menstrual, Unscented (HEB) (7)

Premarket Exempt

Clear

Rael Organic Cotton Tampons: Regular Absorbancy - 00856032008442 Catalog Number :

Device Description : A traditional unscented menstrual 100% organic cotton tampon consisting of an ab 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.

Device Class : 2

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 1

RAEL - 00856032008947 Catalog Number :

Device Description : Organic cotton cardboard applicator tampons, regular absorbency. Distributed in bulk.

Device Class :

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 1920

RAEL - 00856032008954 Catalog Number :

Device Description : Organic cotton cardboard applicator tampons, super absorbency. Distributed in bulk.

Device Class :

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 1540

RAEL - 00859306006205 Catalog Number :

Device Description : Organic cotton cardboard applicator tampons, regular absorbency.

Device Class :

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 16

RAEL - 00859306006212 Catalog Number :

Device Description : Organic cotton cardboard applicator tampons, super absorbency.

Device Class :

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 14

RAEL - 00859306006229 Catalog Number :

Device Description : Organic cotton non-applicator tampons, regular absorbency.

Device Class :

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 18

RAEL - 00859306006236 Catalog Number :

Device Description : Organic cotton non-applicator tampons, super absorbency.

Device Class :

Duns Number: 087378348

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 18

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