FDA Registration
Active
🇮🇳 India
Ansell Sterile Solutions Pvt. Ltd
Reg #: 3024706752
·
FEI: 3024706752
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Ansell Sterile Solutions Pvt. Ltd
- Registration Number
- 3024706752
- FEI Number
- 3024706752
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot No-KK 10, KK-11, SIPCOT Industrial Park, Phase-II, 3rd Cross Road, Perundurai
- City
- Erode Tamil Nadu
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K000295
Owner / Operator
- Firm Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Operator Number
- 8020065
- Address
- 2301 Robb Drive
- City
- Reno
- State
- NV
- Postal Code
- 89523
- Country
- US
- Correspondent
- Don Cronk
US Agent
- Business Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Contact Name
- Don Cronk
- Address
- 2301 Robb Drive
- City
- Reno
- State
- NV
- ZIP
- 89523
- Country
- US
- [email protected]
- Phone
- 775 4707106
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2015-04-29 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2015-04-29 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-12-19 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2016-11-03 |
Proprietary Names
PI Hybrid Micro
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device