FDA Registration
Active
🇺🇸 United States
Scribe Opco, LLC
Reg #: 2111760
·
FEI: 2111760
·
Expires 2026
Products
7
Proprietary Names
33
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Scribe Opco, LLC
- Registration Number
- 2111760
- FEI Number
- 2111760
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5151 Moundview Dr
- City
- RED WING
- State
- MN
- ZIP
- 55066
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101387
Owner / Operator
- Firm Name
- SCRIBE OPCO, INC., dba Koozie Group
- Operator Number
- 9010937
- Address
- 5151 Moundview Drive
- City
- Red Wing
- State
- MN
- Postal Code
- 55066
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 1998-03-16 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-11-23 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2007-12-06 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2001-07-06 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2007-12-06 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-07 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-07 |
Proprietary Names
40069 Custom Printed White Bandages
Norwood Adhesive Bandages Stock
40070 Custom Printed Tattoo Bandages
NORWOOD-WASHBURN LABORA
41163 - Digital Thermometer
Protector Hearing Insert
Sunglasses
40730 First Aid Kit For Burns
40122 Travelin Companion
40729 Sport Kit
40011 Pocket First Aid Kit
40039 Translucent Personal First Aid Kit
40731 Recovery Kit
40047 Personal First Aid Kit
40429 Frosty Clipper First Aid Kit
40728 Jet Setter Kit
40626 Montana Cross First Aid Kit
40382 Redi First Aid Pack
40045 Deluxe First Aid Kit
40049 First Aid Wallet
40399 Family Pack First Aid Kit
20417 Retro First Aid Tin
40397 Basic First Aid Kit
40512 Frosty Stripe First Aid Kit
40101 Sports Injury First Kit
40625 Montana First Aid Kit
40044 Compact First Aid Kit
40472 Carabiner First Aid Kit
40162 Pain Relief Pocket Pack
40343 First Care Kit
40040 First Aid Pouch
3 PLY DISPOSABLE MASK
Face Shield
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device