The Stork® OTC

GUDID 00810396020007

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.

STORK IB2C, INC., THE

Conceptive cervical cap, single-use

• Primary Device ID: 00810396020007
• NIH Device Record Key: fdacf072-9f16-470e-82cc-db4e2662226c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Stork® OTC
• Version Model Number: USOTC
• Company DUNS: 968804521
• Company Name: STORK IB2C, INC., THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 412-200-7996
• Email: info@rinovum.com
• Phone: 412-200-7996
• Email: info@rinovum.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810396020007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140186

FDA Product Code

• OBB: Kit, Conception-Assist, Home Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-01

Devices Manufactured by STORK IB2C, INC., THE

• 00810396020007 - The Stork® OTC: 2018-07-06The 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.
• 00810396020007 - The Stork® OTC: 2018-07-06 The Stork® OTC packages include: Instructions for Use (IFU), one Conceptacle® and one plastic applicator. Once the couple has
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