The Stork OTC

Primary DI
00810396020199
Brand
The Stork OTC
Company
STORK IB2C, INC., THE
Model
1000-019
Device description
The Stork OTC, General
Published
2017-10-11
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
00810396020199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810396020199008103960201998103960201990810396020199

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
00810396020007The Stork® OTCUSOTC2016-10-01
00810396020083The Stork OTC1000-0082017-10-11
00810396020090The Stork OTC1000-0092017-10-11
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
00810396020304The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020311The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020335The Stork OTCSTORK IB2C, INC., THEOBB2017-10-11
00810396020007The Stork® OTCSTORK IB2C, INC., THEOBB2016-10-01