FDA Registration
Active
🇺🇸 United States
CRYOTHERM GEL POUCH ONLY 5.75" x 11.5"
Reg #: 1218997
·
FEI: 1218997
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- CORFLEX
- Registration Number
- 1218997
- FEI Number
- 1218997
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 669 EAST INDUSTRIAL PARK, DRIVE
- City
- MANCHESTER
- State
- NH
- ZIP
- 03109
- Country
- US
Owner / Operator
- Firm Name
- Corflex Global, LLC
- Operator Number
- 1218997
- Address
- 669 EAST INDUSTRIAL, PARK DRIVE
- City
- Manchester
- State
- NH
- Postal Code
- 03109
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2013-02-13 |
Proprietary Names
CRYOTHERM GEL POUCH ONLY 5.75" x 11.5"
NYLON GEL POUCH ONLY 5.75" x 11.5"
CRYOTHERM POUCH W/GEL 5.75" x 11.5"
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device