FDA Registration
Active
🇺🇸 United States
Ansell Sandel Medical Solutions LLC
Reg #: 3004125670
·
FEI: 3004125670
·
Expires 2026
Products
16
Proprietary Names
5
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- Ansell Sandel Medical Solutions LLC
- Registration Number
- 3004125670
- FEI Number
- 3004125670
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9301 Oakdale Ave Ste 300
- City
- CHATSWORTH
- State
- CA
- ZIP
- 91311
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050649
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2013-08-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2021-05-28 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2011-08-25 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2013-12-20 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2013-09-25 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2016-04-13 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2011-08-26 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2011-08-26 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2013-01-09 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2011-08-26 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2021-02-12 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2011-08-26 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2021-02-22 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-08-26 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2019-09-04 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2011-08-26 |
Proprietary Names
Gammex Silver Barrier Dressing
KIT TURNOVER STAT-PAC
STAT-BLOC Premium, Antimicrobial, Wide Table Sheet (90") w/ Elastic Edging at Head and Foot
STAT-STRAP
Sandel Safety Scalpel Non-Sterile
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device