FDA Registration
Active
🇨🇦 Canada
STERIS Applied Sterilization Technologies ULC
Reg #: 9680143
·
FEI: 3002807308
·
Expires 2026
Products
25
Proprietary Names
61
Establishment Types
1
Classifications
25
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Registration Details
- Registration Name
- STERIS Applied Sterilization Technologies ULC
- Registration Number
- 9680143
- FEI Number
- 3002807308
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 184 CROWN CT.
- City
- WHITBY Ontario
- Country
- CA
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2019-12-27 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2019-12-26 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2018-04-27 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2019-12-27 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2012-11-14 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2024-01-02 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2012-10-30 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2020-10-23 |
| Topical Approximation System | MZR | Class 1 | General Hospital | No | 2020-10-23 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2019-10-31 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2014-03-03 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2013-01-28 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2019-12-27 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2012-12-27 |
| Strip, Adhesive, Closure, Skin | FPX | Class 1 | General Hospital | No | 2019-12-27 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2019-12-27 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2012-11-14 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2019-12-27 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2012-11-14 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2014-03-03 |
Proprietary Names
DermaSci1232 (WT) - oil emulsion
DermaSci1232 (WT) - honey alginate
DermaSci1232 (WT) - Medihoney Hydrogel Colloidal Sheet
DermaSci1232 (WT) - sterile water
DermaSci1232 (WT) - sterile saline
MML1375 (SN) - MML Specimen Collection Swab
Ensera7760 (GR,SP) - Sterile Flocked Swab
Ensera7760 (GR,SP) - SteriPack Sterile Polyester Spun Swab
Ensera7760 (LN,SP) - Sterile 3" Foam Swab with yellow handle v2
Puritan5503 (NR) - CaligSwab; HydraFlock; PurFlock Ultra; Puritan, Pur-Wraps; PurSwab
SteriPackUSA7760 (SP) - Sterile Foam Swab with yellow handle
Puritan5503 (NR) - Sterile Foam Tipped Applicator
Puritan5503 (NR) - Hospital, Sterile Cotton Tipped Applicators
Robling1585 (SP) - ClearTip Swab Ultra Thin
Birchwood1772 (MN) - Scopettes JR
Puritan5503 (NR) - Sterile Cotton Tipped Applicators
Puritan5503 (NR) - Puritan, Sterile Polyester Tipped Applicators
DermaSci1232 (WT) - Medihoney Honeycolloid Dressing
Pretium1202 (WT)- Starplex Starswab 2 Bacteriology Culture Collection BactiSwab LiquidFisherfinest Bacteriology Culture
VerathonMedical5877 (WT) - GlideScope Ranger Single Use
VerathonMedical5877 (WT) - GlideScope AVL Single Use
VerathonMedical5877 (WT) - GlideScope GVL Single Use
DermaSci1232 (WT,LN) - Medihoney
DermaSci1232 (WT) - petrolatum
DermaSci1232 (WT) - Xeroform
DermaSci1232 (WT) - suture strips plus
DermaSci1232 (WT) - Wound Closure Strips
DermaSci1232 (WT) - Shur Strip
DermaSci1232 (WT) - iodoform guaze
DermaSci1232 (WT) - dermagran B
DermaSci1232 (WT) - Saline wet dressing
DermaSci1232 (WT) - Water wet dressing
Pretium1202 (WT) - Leakbuster
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag with Procedure Pack (Ref 622281)
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280)
Merit1383 (SN) - Cultura Saliva Self Collection Kit
PFMMedical6614 (TM) - ASEPT 2,000mL Drainage Bag (Ref M7058)
PFMMedical (TM) - ASEPT 2,000mL Drainage Bag with Procedure Pack (Ref M7060)
CorningME1979 (CH1) - Corning Closed Systems individually wrapped centrifuge tubes and accessories
BD4590 (SP) - BD Vacutainer® No Additive (Z) Plus Tubes
Merit1383 (SN,NT) - PAL - Pen and Labels
KeySurgica6941 (LS) - Sterile Labels
RMAC1276 (WT) - PharmaTags
BeInnovative11045 (LN) - Rotolock Cord Management System
Hydrofera (NR, WH) - Instrument Wipe
SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R
Etex2142 (NR) - Precision Cannula 150 mm
PhoenixMed2991 (SP) - Various Instruments
Acuderm1463 (WH,LS) - Acu-Dispo-Ce
PhoenixMed2991 (SP) - Instrument, manual, surgical, general use
Abyrx4508 (WH) - Abyrx Putty Applicator
Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Protech3048 (TM) - PHANTOM ML LIGHT CABLE
Design2052 (NR) - CTS Relief Kit
Merit1383 (SN,NT) - Futura Safety Scalpel
BVI1689 (EP1) - Beaver Sclerotome Blade
BVI1689 (EP1) - Beaver Mini-Blades
BVI1689 (EP1) - Beaver Pocket Blade
BVI1689 (EP1) - BeaverGuard Blade
VerathonMedical5877 (WT) - GlideRite Single-Use Stylet - Small
VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)