FC2 Female Condom® 200117
GUDID 00861783000102
FC2 Female Condom®
Veru Inc.
Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer| Primary Device ID | 00861783000102 |
| NIH Device Record Key | 3963f7a7-17dc-4f0a-a71d-fd4b713292b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FC2 Female Condom® |
| Version Model Number | 200117 |
| Catalog Number | 200117 |
| Company DUNS | 055300578 |
| Company Name | Veru Inc. |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Dimensions
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
| Length | 170 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place away from direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861783000102 [Unit of Use] |
| GS1 | 00861783000126 [Primary] |
| GS1 | 10861783000123 [Package] Contains: 00861783000126 Package: Case [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P080002
FDA Product Code
| MBU | Condom, female, single-use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-19 |
| Device Publish Date | 2021-05-11 |
Trademark Results [FC2 Female Condom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FC2 FEMALE CONDOM 97660824 not registered Live/Pending |
Veru, Inc. 2022-11-03 |
 FC2 FEMALE CONDOM 86198751 4620277 Live/Registered |
VERU INC. 2014-02-20 |
 FC2 FEMALE CONDOM 78837829 3773603 Live/Registered |
VERU INC. 2006-03-15 |
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