The Stork OTC

The Stork® OTC packages include: Instructions for Use (IFU), one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC…

Registry build 21.09.26

The Stork® OTC packages include: Instructions for Use (IFU), one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female’s most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

1manufacturer
7catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OBB
Manufacturer City Province Registered as Device types
Immetech Industrial Co., Ltd. Dongguan Guangdong Contract manufacturer 2

Record

Regulatory record for The Stork OTC
Listed by Stork IB2C, Inc., THE
FDA product code OBB
Device type Kit, Conception-Assist, Home Use
Device class Class 2
Regulation 21 CFR 884.5250
510(k) K140186
Record published 2017-10-11
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Keep Away from Sunlight; Special storage condition: Keep Dry; Storage environment temperature -30 to 54 °C

Catalogue Numbers

Catalogue numbers for The Stork OTC
Catalogue number Size Status
1000-008 In distribution
1000-009 In distribution
1000-030 In distribution
1000-031 In distribution
1000-033 In distribution
USOTC In distribution
1000-019 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Conception Kit Conceivex, Inc. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer