FDA Registration
Active
🇺🇸 United States
NuncTM IVF ICSI Dish (150265)
Reg #: 1314344
·
FEI: 1000087290
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Nalge Nunc International Corporation
- Registration Number
- 1314344
- FEI Number
- 1000087290
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 75 Panorama Creek Dr
- City
- Rochester
- State
- NY
- ZIP
- 14625
- Country
- US
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2018-12-24 |
Proprietary Names
NuncTM IVF ICSI Dish (150265)
NuncTM IVF Dishes (60mm), Nontreated (150270)
NuncTM IVF MultiDish 4-Well, Nontreated (179830)
NuncTM IVF Dishes (35mm), Nontreated (150255)
NuncTM IVF Dishes (90mm), Nontreated (150360)
NuncTM IVF MultiDish 4-Welll, Nunclon (144444)
NuncTM IVF Center Well Dish (150260)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198