AccessGUDID - DEVICE: FemCap (00863008000102)

GUDID

Device Identifier (DI) Information

Brand Name: FemCap
Version or Model: 22 mm small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-399-22
Company Name: FEMCAP, INC.

Primary DI Number: 00863008000102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140036166 *Terms of Use

Device Description: FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
46971	Contraceptive cervical cap, reusable	A contraceptive device that is inserted into the cervix where it acts as a physical barrier to prevent semen from entering the uterus. It is typically a soft rubber cup with a round rim that is sized by a healthcare professional to fit snugly around the cervix. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLQ	Cap, Cervical, Contraceptive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 22 mm

Device Record Status

Public Device Record Key: 5cd92fc8-e41d-4ece-adb1-10df246c9e34
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 15, 2016