| Primary Device ID | 00810000318162 |
| NIH Device Record Key | 55ecaf9b-5ac9-45ce-aa1a-eee19601cde1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mederma Cold Sore 15ct |
| Version Model Number | 810000318162 |
| Company DUNS | 081160441 |
| Company Name | HRA PHARMA AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | 862-260-9988 |
| b.meeks@HRA-PHARMA.COM |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000318162 [Primary] |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
| 00810000318018 - Compeed Advanced Blister Care Medium 12p | 2023-04-03 Blister Support Bandage Cushion |
| 00810000318025 - Compeed Advanced Blister Care Sports Mixed 9p (6+3) | 2023-04-03 Blister Support Bandage Cushion |
| 00810000318292 - Compeed Advanced Blister Care Medium Skin Tone x10 | 2023-04-03 Blister Support Bandage Cushion |
| 00810000310371 - Compeed Advanced Blister Care Mixed 6 | 2023-02-23 Blister Support Bandage Cushion |
| 00810000310265 - Mederma Medical Grade Silicone Scar Sheet Large 4ct | 2022-08-16 Silicone sheets for scar management |
| 00810000310258 - Mederma Medical Grade Silicone Scar Sheet Small 4ct | 2022-02-14 Silicone sheets for scar management |
| 00810000318162 - Mederma Cold Sore 15ct | 2020-10-12Mederma Cold Sore Discreet Healing Patch |
| 00810000318162 - Mederma Cold Sore 15ct | 2020-10-12 Mederma Cold Sore Discreet Healing Patch |
| 00810000310012 - Compeed Blister Medium 5p USA | 2020-07-13 Blister Support Bandage Cushion |