PRO-SIL PROK-111
GUDID 00852260000173
Pro-Sil Kids 4.25g
BIODERMIS CORPORATION
Scar management dressing, reusable| Primary Device ID | 00852260000173 |
| NIH Device Record Key | afd89a1e-2646-4f0f-9d9d-4584df498f84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO-SIL |
| Version Model Number | PROK-111 |
| Catalog Number | PROK-111 |
| Company DUNS | 809650005 |
| Company Name | BIODERMIS CORPORATION |
| Device Count | 1 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852260000173 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003948
FDA Product Code
| MDA | Elastomer, Silicone, For Scar Management |
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 | 2020-09-04 |
| Device Publish Date | 2020-08-27 |
On-Brand Devices [PRO-SIL]
| 00852260000999 | PRO-SIL 4.25g Tube |
| 00852260000296 | Pro-Sil SPF 15 17g |
| 00852260000289 | Pro-Sil SPF 15 4.25g |
| 00852260000173 | Pro-Sil Kids 4.25g |
| 00852260000166 | Pro-Sil 17g |
| 00852260000159 | Pro-Sil 4.25g |
Trademark Results [PRO-SIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-SIL 86733221 5024015 Live/Registered |
Bull Bond Manufacturing Corp. 2015-08-21 |
 PRO-SIL 86593328 not registered Dead/Abandoned |
Lukos Enterprises, LLC 2015-04-10 |
 PRO-SIL 79045383 3534286 Live/Registered |
Infineon Technologies AG 2007-09-11 |
 PRO-SIL 78465469 3086529 Live/Registered |
BIODERMIS CORPORATION 2004-08-11 |
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