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| 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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