FDA UDI
In Commercial Distribution
🇺🇸 United States
FC2 Female Condom®
DI: 00861783000126
·
Model: 200117
·
Veru Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- FC2 Female Condom®
- Primary DI
- 00861783000126
- Version / Model
- 200117
- Catalog Number
- 200117
- Company Name
- Veru Inc.
- Labeler DUNS
- 055300578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2021-05-11
- Public Version
- 2
- Public Version Date
- 2021-08-04
- Public Version Status
- Update
- Public Device Record Key
- 3963f7a7-17dc-4f0a-a71d-fd4b713292b2
Device Description
FC2 Female Condom®
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MBU | Condom, female, single-use | Obstetrics/Gynecology | 884.5340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00861783000102 | GS1 | ||||
| Primary | 00861783000126 | GS1 | ||||
| Package | 10861783000123 | GS1 | Case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(312)968-4713
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080002 | 000 |
| P080002 | 002 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 170 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place away from direct sunlight