AccessGUDID - DEVICE: FC2 Female Condom® (00861783000126)

GUDID

Device Identifier (DI) Information

Brand Name: FC2 Female Condom®
Version or Model: 200117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200117
Company Name: Veru Inc.

Primary DI Number: 00861783000126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 055300578 *Terms of Use

Device Description: FC2 Female Condom®

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:	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?
47722	Female condom, synthetic polymer	A sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. It typically includes a lubricant to minimize friction during coitus. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MBU	Condom, female, single-use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080002	000
P080002	002

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: Store in a cool dry place away from direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 170 Millimeter

Device Record Status

Public Device Record Key: 3963f7a7-17dc-4f0a-a71d-fd4b713292b2
Public Version Date: August 04, 2021
Public Version Number: 2
DI Record Publish Date: May 11, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10861783000123	6	00861783000126		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00861783000102 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: +1(312)968-4713
Email: Kgilbert@verupharma.com

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