FDA Registration
Active
🇺🇸 United States
18785 TaperGuard size 8.5
Reg #: 1721686
·
FEI: 1721686
·
Expires 2025
Products
1
Proprietary Names
46
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1721686
- FEI Number
- 1721686
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2400 Airport Rd
- City
- Santa Teresa
- State
- NM
- ZIP
- 88008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090352
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2013-06-06 |
Proprietary Names
18785 TaperGuard size 8.5
18750 TaperGuard size 5
18860 TaperGuard Evac size 6
18890 TaperGuard Evac size 9
18710S Taperguard, 10, W/STYLET
18755S Taperguard, 5.5, W/STYLET
18790S Taperguard, 9, W/STYLET
18770 TaperGuard size 7
18790 TaperGuard size 9
18765S Taperguard, 6.5, W/STYLET
18880 TaperGuard Evac size 8
18755 TaperGuard size 5.5
18750S Taperguard, 5, W/STYLET
18775 TaperGuard size 7.5
18780 TaperGuard size 8
18870 TaperGuard Evac size 7
18875 TaperGuard Evac size 7.5
18770S TAPERGUARD, 7, W/STYLET
18775S TAPERGUARD, 7.5, W/STYLET
18760 TaperGuard size 6
18795 TaperGuard size 9.5
18760S Taperguard, 6, W/STYLET
18785S Taperguard, 8.5, W/STYLET
18765 TaperGuard size 6.5
18780S TAPERGUARD, 8, W/STYLET
18865 TaperGuard Evac size 6.5
18710 TaperGuard size 10
86462 3 Uncuffed Tracheal Tube Magill
86225 4 Uncuffed Tracheal Tube Murphy
86467 5.5 Uncuffed Tracheal Tube Magill
86464 4 Uncuffed Tracheal Tube Magill
86265 4 Oral RAE Tracheal Tube Uncuffed
86645 4 Uncuffed Tracheal Tube W/Mon Lumen
86463 3.5 Uncuffed Tracheal Tube Magill
18885 TaperGuard Evac size 8.5
86224 3.5 Uncuffed Tracheal Tube Murphy
86228 5.5 Uncuffed Tracheal Tube Murphy
86658 5.5 Uncuffed Tracheal Tube W/Mon Murphy Eye
76275 Oral RAE TaperGuard Cuffed 7.5mm
86222 2.5 Uncuffed Tracheal Tube Murphy
86461 2.5 Uncuffed Tracheal Tube Magill
86223 3 Uncuffed Tracheal Tube Murphy
86229 6 Uncuffed Tracheal Tube Murphy
86646 4.5 Uncuffed Tracheal Tube W/Mon Lumen
86226 4.5 Uncuffed Tracheal Tube Murphy
8888247023 Nasopharyngeal Airway 26 FR
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)