The Stork® OTC
Basic Information
- Brand Name
- The Stork® OTC
- Primary DI
- 00810396020007
- Version / Model
- USOTC
- Company Name
- STORK IB2C, INC., THE
- Labeler DUNS
- 968804521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fdacf072-9f16-470e-82cc-db4e2662226c
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OBB | Kit, Conception-Assist, Home Use | Obstetrics/Gynecology | 884.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61449 | Conceptive cervical cap, single-use | A flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device which may have a condom-like sheath for semen collection, and may be supplied with a dedicated applicator. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810396020007 | GS1 |
Customer Contacts
- Phone
- 412-200-7996
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140186 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 54 Degrees Celsius