FDA Registration
Active
🇺🇸 United States
CORNING-KENNEBUNK
Reg #: 1218905
·
FEI: 1218905
·
Expires 2026
Products
7
Proprietary Names
22
Establishment Types
3
Classifications
7
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Registration Details
- Registration Name
- CORNING-KENNEBUNK
- Registration Number
- 1218905
- FEI Number
- 1218905
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Alfred Rd
- City
- KENNEBUNK
- State
- ME
- ZIP
- 04043
- Country
- US
Owner / Operator
- Firm Name
- Corning Incorporated
- Operator Number
- 1317452
- Address
- 836 North Street, Building 300
- City
- Tewksbury
- State
- MA
- Postal Code
- 01876
- Country
- US
- Correspondent
- Amber Aagaard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2002-02-15 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2012-11-12 |
| Spinner, Flask | KJD | Class 1 | Hematology | No | 2013-10-28 |
| Spinner System, Cell Culture | KJE | Class 1 | Hematology | No | 2011-10-27 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2008-02-11 |
| Bottle, Roller, Tissue Culture | KJC | Class 1 | Hematology | No | 2012-11-12 |
| System, Suspension, Cell Culture | KJF | Class 1 | Hematology | No | 2012-09-24 |
Proprietary Names
Primaria flasks greater than 100 square cm surface area. PureCoat Flasks various sizes.
Falcon, Costar and Corning CELLBIND cell culture flasks greater than 100 square cm surface area
Synthemax Flasks sizes greater than 100 square cm surface area
Falcon MultiFlasks, various styles greater than 100 square cm surface area
Corning Erlenmeyer Flasks, various sizes;
Corning PureCoat rLaminin-521 Cultureware; various sizes
HYPERFlasks and HYPERStack vessels and accessories; various styles and sizes
CellCube Systems and accessories, various styles and sizes
CellSTACK Culture Chambers and accesories, various styles and sizes
PureCoat Flasks various sizes
Corning Closed Systems individually wrapped centrifuge tubes and accessories
Falcon Individually Wrapped Round-Bottom Tubes;
Corning Cryogenic vials and accessories;
Containers
Corning Spinner Flasks and accessories, various styles and sizes
Corning Disposable Spinner Flasks
Tissue Culture Dish and BioAssay Dish
Custom Transwell Permeable Supports > 100 cm2; PureCoat Cell Culture Plates and Dishes, various Styles and Sizes
Corning and Custom roller bottles and accessories
Corning CellBIND roller bottles and accessories;
Corning Easy Grip Storage Bottle and accessories
Corning Polystyrene Microcarrier beads, Corning Synthemax Microcarrier beads
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)