FC2 Female Condom® 200117
GUDID 00861783000102
FC2 Female Condom®
Veru Inc.
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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