FDA Registration
Active
🇨🇦 Canada
PRETIUM CANADA PACKAGING ULC
Reg #: 8020315
·
FEI: 5804
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- PRETIUM CANADA PACKAGING ULC
- Registration Number
- 8020315
- FEI Number
- 5804
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 50-A STEINWAY BLVD.
- City
- ETOBICOKE Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K943499
Owner / Operator
- Firm Name
- PRETIUM CANADA PACKAGING ULC
- Operator Number
- 8020315
- Address
- 50-A STEINWAY BLVD., --
- City
- ETOBICOKE
- State
- Ontario
- Postal Code
- M9W 6Y3
- Country
- CA
- Correspondent
- TIFFANY - DAVIS
US Agent
- Business Name
- Starplex Scientific Corp
- Contact Name
- Lisa Clayton
- Address
- 705 Industrial Drive SW
- City
- Cleveland
- State
- TN
- ZIP
- 37311
- Country
- US
- [email protected]
- Phone
- 423 5996059
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 1980-07-28 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2018-08-03 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2014-12-10 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2007-12-07 |
| Culture Media, Anaerobic Transport | JSL | Class 1 | Microbiology | No | 2007-12-07 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2007-12-07 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2007-12-07 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2001-06-15 |
Proprietary Names
Leakbuster
Leakbuster Space Saver
Urine Culture and Urinalysis Preservative Tube (V102-CA)
Spout Cap
Quick Turn
Starswab II Bacteriology Culture Collection and Transport System
Pinworm Collector (V302-PIN)
Starswab Anaerobic Transport System
Multitrans System
Histoplex Specimen Containers
Starswab Dry Swab
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device