AccessGUDID - DEVICE: The Stork OTC (00810396020304)

GUDID

Device Identifier (DI) Information

Brand Name: The Stork OTC
Version or Model: 1000-030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STORK IB2C, INC., THE

Primary DI Number: 00810396020304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968804521 *Terms of Use

Device Description: Stork OTC, General, S-Box

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBB	Kit, Conception-Assist, Home Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140186	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: between -30 and 54 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6f037ab-6445-47cf-b4e8-8c04859734ce
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 11, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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