Scribe OpCo - Kit 3.1
2024-01-10
Scribe Opco, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2111760 | 2111760 | Scribe Opco, LLC | 1 | N | 2026-01-01 | 5151 Moundview Dr RED WING MN US 55066 |
| 3043840147 | 3043840147 | SCRIBE OPCO, LLC DBA KOOZIE GROUP | 1 | N | 2026-01-01 | 14799 Shady Hills Rd Spring Hill FL US 34610 |
| 3013704693 | 3013704693 | Scribe OpCo, Inc. | 1 | Y | 2020-04-25 | 14421 Myerlake Circle Clearwater FL US 33760 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 15081 | 1456270021 | K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | FLL | 2010-08-03 |
| 15081 | 1109008766 | ||||
| 15081 | 1261153674 | ||||
| 15081 | 1245491319 | ||||
| 15081 | 1343938393 | ||||
| 15081 | 1361151903 | ||||
| 349390 | 1375389222 | ||||
| 15081 | 1518993890 | ||||
| 349390 | 1705246474 | ||||
| 15081 | 1792227829 | ||||
| 349390 | 1876358601 | ||||
| 15081 | 1916167420 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FLL | 1 | 2010-08-03 |
GUDID#
Scribe OpCo - Kit 6
2023-01-03
Scribe OpCo - Kit 5
2023-01-03
Scribe OpCo - Kit 4
2023-01-03
Scribe OpCo - Kit 3
2023-01-03
Scribe OpCo - Kit 2
2023-01-03
Scribe OpCo - Kit 1
2023-01-03
Scribe OpCo - Custom Tattoo bandage in white or colored dispenser
2023-01-03
Scribe OpCo - Custom White Bandage in White or Colored Dispenser
2023-01-03
Bandage - Custom tattoo bandage
2023-01-03
Bandage - Custom white bandage
2023-01-03
Bandage - Standard
2023-01-03