FDA Registration
Active
🇺🇸 United States
CROSSTEX INTERNATIONAL, INC.
Reg #: 3006008984
·
FEI: 3006008984
·
Expires 2026
Products
5
Proprietary Names
16
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CROSSTEX INTERNATIONAL, INC.
- Registration Number
- 3006008984
- FEI Number
- 3006008984
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 534 VINE STREET
- City
- SHARON
- State
- PA
- ZIP
- 16146
- Country
- US
Regulatory Submissions
- 510(k) Number
- K941327
Owner / Operator
- Firm Name
- Crosstex International
- Operator Number
- 2433773
- Address
- 6789 WEST HENRIETTA RD., --
- City
- Rush
- State
- NY
- Postal Code
- 14543
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2014-10-28 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2012-02-20 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 1995-10-12 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2012-02-13 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2007-07-10 |
Proprietary Names
Plastic Headrest Cover
MaxVac Plus Combo Tip
Combo-TIp
Duo-Check Sterilization Pouches
Sure-Check Sterilization Pouches
Syringe Sleeves
Tray Sleeve
X-Ray Sleeves
Barrier Film
Air/water Syringe Sleeve
Safe-Flo Saliva Ejectors
Safe-Flo Saliva Ejector Valve
Saliva Ejector
PREMIUM SALIVA EJECTORS
Comfort Plus Premium Saliva Ejector
Advantage Saliva Ejector
Establishment Types
Manufacture Medical Device