The Stork® OTC

Primary DI
00810396020007
Brand
The Stork® OTC
Company
STORK IB2C, INC., THE
Model
USOTC
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.
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBBKit, Conception-Assist, Home Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBBKit, Conception-Assist, Home UseObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140186000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140186000THE STORK OTCRinovum Women'S Health, Inc.2014-07-11OBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810396020007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810396020007008103960200078103960200070810396020007

GMDN Terms#

Term, Definition table
TermDefinition
Conceptive cervical cap, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Sunlight
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature-30 Degrees Celsius54 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
412-200-7996info@rinovum.com

Regulatory Flags#

DUNS number
968804521
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810396020083The Stork OTC1000-0082017-10-11
00810396020090The Stork OTC1000-0092017-10-11
00810396020199The Stork OTC1000-0192017-10-11
00810396020304The Stork OTC1000-0302017-10-11
00810396020311The Stork OTC1000-0312017-10-11
00810396020335The Stork OTC1000-0332017-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065015660064Béa FertilitySTEPONE FERTILITY LTDOBB2025-07-24
00895863001000Conception KitCONCEIVEX INC.OBB2018-09-01
00810396020083The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020090The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020199The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020304The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020311The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020335The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11