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The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.

The TOSAMA Reusable Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold in three different packaging configurations: Applicator with prepackaged tampons (regular, super and super plus absorbency versions) and Applicator with loose tampons of super and regular absorbency. The device is comprised of a tampon holder and pusher made of thermoplastic elastomer and a lipstick-style cap to protect the applicator, which is made of polystyrene. The tampon holder and pusher are connected at the hinged base of the holder, which opens to load a tampon and closes to allow the pusher to eject a tampon. The holder and pusher are designed to stay connected and not separate during use, storage, or cleaning. The TOSAMA Reusable Applicator requires the user to load the applicator with a legally marketed menstrual tampon. The use-life of the subject TOSAMA Reusable Applicator is 2 years. The device requires the user to clean (holder and pusher) and disinfect (lipstick cap) before initial use, before long term storage and at the end of the menstrual cycle, as well as to clean the device after each use. The applicator is available in one size for all sizes of tampon absorbencies (Light, Regular, Super and Super Plus) and accommodates a maximal tampon diameter of 15 mm. The holder inner diameter is 8.2 + 0.25/- 0.10 mm, pusher length is 83.7 ±0.5 mm and total length and diameter of the applicator (without the lipstick cap) is 70.8 ± 1.0 mm and 19.6 ±0.05 mm respectively.

The Tosama Biobased Applicator Tube Menstrual Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

The device will be offered as a traditional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator comprised of biobased plastic. 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 three absorbencies: Regular, Super, and Super Plus.