FDA Registration
Active
🇺🇸 United States
COLE INSTRUMENTS
Reg #: 3009381954
·
FEI: 3009381954
·
Expires 2026
Products
17
Proprietary Names
30
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- COLE INSTRUMENTS
- Registration Number
- 3009381954
- FEI Number
- 3009381954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1090 Powers Pl
- City
- Alpharetta
- State
- GA
- ZIP
- 30009
- Country
- US
Owner / Operator
- Firm Name
- Cole Instruments
- Operator Number
- 10038436
- Address
- 1070 Powers Place
- City
- Alpharetta
- State
- GA
- Postal Code
- 30009
- Country
- US
- Correspondent
- Chris Miller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2011-10-13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2022-12-05 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2011-10-21 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2013-12-18 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2014-12-12 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2022-12-05 |
| Epilator, High Frequency, Tweezer-Type | KCX | Class 1 | General, Plastic Surgery | No | 2021-12-13 |
| Sieves, Tissue | IDX | Class 1 | Pathology | No | 2021-12-13 |
| Template | HWT | Class 1 | Orthopedic | No | 2021-12-13 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2022-12-05 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2012-12-17 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2011-10-13 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-12-08 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2011-10-13 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2011-12-08 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2011-10-17 |
| Accessories To Examination Light | PEQ | Class 1 | General Hospital | No | 2021-12-13 |
Proprietary Names
Aide To Extract
ATOE
Assist to Extract
Assist to Hairline Device - Reusable
Cole Electric Chilling Device
Graft Washing Station
Electric Chilling Device Single
Electric Chilling Device Double
Powered Cole Isolation Device
PCID
SFD valve accessory
Ring Cup 2-pocket
Tweezers
Graft Cleaning Bowl
Donor Template
AHSAD
Graft Storage Plate
Vortex
Cole Instruments Punch
CII Punch
SFD
Self Filling Injection Device Handle
Cole Manual Punch Holder
CIT Manual Punch Holder
Cole Forceps
Cole Cutting Board
Graft Processing Board
Cole Slivering Board
Graft Slivering Board
Graft Board LED back light
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198