Nova Gel GEL-6505
GUDID 00855638007125
: NovaGel is indicated for use as a scar management dressing on old and new hypertrophic or keloid scars.
STELLEN MEDICAL, LLC
Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable| Primary Device ID | 00855638007125 |
| NIH Device Record Key | 6f6a80ba-d5f6-49ca-a416-43d2fa7baaed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nova Gel |
| Version Model Number | GEL-6505 |
| Catalog Number | GEL-6505 |
| Company DUNS | 801160037 |
| Company Name | STELLEN MEDICAL, LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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
Device Dimensions
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
| Width | 6 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855638007125 [Primary] |
| GS1 | 00855638007132 [Package] Package: Box [5 Units] In Commercial Distribution |
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 | 2020-10-30 |
| Device Publish Date | 2020-10-22 |
Devices Manufactured by STELLEN MEDICAL, LLC
| 00855638007149 - Brennen Skin Graft Mesher | 2022-08-18 The Skin Graft Mesher is a surgical instrument designed to expand skin grafts. |
| 00855638007156 - Brennen Skin Graft Mesher | 2022-08-18 The Skin Graft Mesher is a surgical instrument designed to expand skin grafts. |
| 00855638007163 - Brennen Skin Graft Mesher | 2022-08-18 The Skin Graft Mesher is surgical instrument designed to expand skin grafts. |
| 00855638007170 - Brennen Skin Graft Mesher | 2022-08-18 The Skin Graft Mesher is a surgical instrument designed to expand skin grafts. |
| 00855638007187 - Brennen Skin Graft Mesher | 2022-08-18 The Skin Graft Mesher is a surgical instrument designed to expand skin grafts. |
| 00855638007194 - Brennen Skin Graft Mesher | 2022-08-18 The Skin Graft Mesher is a surigical instrument designed to expand skin grafts. |
| M070PR02051 - Proformix | 2022-06-10 Multi-purpose Implantable surgical mesh, collagen, bioabsorable- for use in procedure such as achilles repair, rotator cuff and |
| M070PR04071 - Proformix | 2022-06-10 Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as achilles repair, rotator cuff and |
Trademark Results [Nova Gel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVA GEL 87596838 not registered Dead/Abandoned |
Nguyen, John 2017-09-05 |
 NOVA GEL 77968875 3879165 Dead/Cancelled |
Inova Diagnostics, Inc. 2010-03-25 |
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