FDA Registration
Active
🇺🇸 United States
Reprocessed surgical instruments
Reg #: 2011171
·
FEI: 2011171
·
Expires 2025
Products
1
Proprietary Names
344
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 2011171
- FEI Number
- 2011171
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4900 Gifford Ave
- City
- Los Angeles
- State
- CA
- ZIP
- 90058
- Country
- US
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 |
|---|---|---|---|---|---|
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2012-11-01 |
Proprietary Names
Reprocessed surgical instruments
Y-TEC Peritoneal Dialysis Catheter Implantation Pacs
Cuff Implantor
KI9384/12
12-203/20
14901/25
17705/10
KI086SS/20
19-360/20
24-689SPC/20
25-710/20
SOAR Beveled Portal Tube Catalog# 306-1804
SOAR Portal Tube Catalog# 304-1507
Argyle Vascular Tourniquet Kit
17050/50
19245/50
17441/24
25-705/20
KI922/20
KI031/20
17771/100
15202/100
KI076/50
17024/20
25-107/20
17455/50
KI028/20
KN2405/10
27-734R/60
11-177 RED/20
KI0104/50
KI160/20
11-159A/20
25-749/20
17630/20
17713/20
OEIT01/20
32-914/20
SOAR Beveled Portal Tube Catalog# 306-1509
SOAR Beveled Portal Tube Catalog# 306-2211
SOAR Beveled Portal Tube Catalog# 306-2212
SOAR Beveled Portal Tube Catalog# 306-1510
SOAR Portal Tube Catalog# 304-1207
HK008/50
25-696/20
17405/48
17033/50
20-372S/20
27-776/20
17130/50
17405/10
19-363/50
16-296/20
SP62/50
14906/20
25-751/20
Spineology Expandable Rake (Toothed) Catalog# 315-0027
SOAR Portal Tube Catalog# 304-1510
KI140/05
11-177 BK/20
28855/20
12-202K/20
17640/15
15202/25
12-206/20
KI0127/50
MED27-752/20
Spineology Expandable Rake (Non-Toothed) Catalog# 315-0028
TOQ634
SOAR Beveled Portal Tube Catalog# 306-1504
KI076NT/20
25-746/20
SOAR Beveled Portal Tube Catalog# 306-1507
19227/20
15001/100
MED25-751/20
MED27-734/20
15232/50
15302/50
19230/20
15101/100
PL-8037/100
24-666/20
KI082/50
MED27-732/20
KN2605/10
KI056/50
2511/25
18-331S/50
KI095/50
24-712/20
SOAR Portal Tube Catalog# 304-1210
SOAR Portal Tube Catalog# 304-1811
SOAR Portal Tube Catalog# 304-1509
27-784-S/20
463-004-PK/20
27-774S/20
17125/50
17406/48
KI032/20
KI032/50
19-366/20
N0522S/24
SOAR Portal Tube Catalog# 304-2210
SOAR Portal Tube Catalog# 304-1806
SOAR Beveled Portal Tube Catalog# 306-1807
SOAR Portal Tube Catalog# 304-1204
SOAR Portal Tube Catalog# 304-2611
SOAR Beveled Portal Tube Catalog# 306-2204
SOAR Beveled Portal Tube Catalog# 306-1810
KS355/50
15201/100
17625/20
KN1415/10
02-445/20
24-710/20
KI079/20
Key Surgical® Vascular Loops
SOAR Portal Tube Catalog# 304-1203
SOAR Portal Tube Catalog# 304-2209
SOAR Beveled Portal Tube Catalog# 306-1508
SOAR Portal Tube Catalog# 304-1209
SOAR Beveled Portal Tube Catalog# 306-2205
MCS100
24-684/20
312-640/20
25-775B/20
17119/50
19221/20
17618/25
17724/50
KN2738/50
27-802/10
KI096S/20
KI081/50
11-138S/20
17358/25
SOAR Beveled Portal Tube Catalog# 306-2209
SOAR Portal Tube Catalog# 304-2205
SOAR Portal Tube Catalog# 304-2606
18-346/20
11-139S/20
25-711/20
TOQ635
17355/50
19902/20
17626/25
32-916/20
29-860/20
17508/24
15221/100
95-551/50
KI074/20
KN2505/10
13-241/20
KI049/20
27-796/20
17624/25
SOAR Portal Tube Catalog# 304-1211
SOAR Portal Tube Catalog# 304-2605
Spineology E Blade Catalog# 315-0014
SOAR Beveled Portal Tube Catalog# 306-1805
SOAR Portal Tube Catalog# 304-1511
SOAR Portal Tube Catalog# 304-1508
19-349FPS/20
KF305/25
17432/24
NED001/10
BHIC01/10
KI084S/20
32-911/20
27-750/20
KN2805/10
25-711A/20
KI026/20
MAGP01/20
KI9390/20
SOAR Beveled Portal Tube Catalog# 306-2207
KI069/20
27-790/20
17566/25
25-702/20
TOQ630
KI0154/20
15301/100
KI150/10
TOQ633
KI083K/50
11-134/20
11-182/50
16-277/20
KI0134/20
27-734/20
KIW95/20
27-736R/60
19222/20
27-784/20
GS94-952/01
KN2615/10
KN7516/25
KN2815/10
KI086S/20
KI078/20
17125/10
11-176 BK/20
27-752/20
24-689B/20
11-119C/20
KI061/50
14-257/20
16-254-LRS/20
17120/50
24-684-A/20
9595/50
KI086/20
KI077/20
25-699/50
25-746S/20
2510/50
SOAR Portal Tube Catalog# 304-1212
SOAR Portal Tube Catalog# 304-1206
TOQ632
19260/20
KI071/20
32-913/20
15205/100
KI0137/20
17360/25
KI122/20
SOAR Portal Tube Catalog# 304-1807
Spineology SIFS Blade Catalog# 330-0012
SOAR Beveled Portal Tube Catalog# 306-2208
SOAR Portal Tube Catalog# 304-1205
SOAR Portal Tube Catalog# 304-2608
SOAR Beveled Portal Tube Catalog# 306-1505
SOAR Portal Tube Catalog# 304-1512
SOAR Beveled Portal Tube Catalog# 306-1812
SOAR Beveled Portal Tube Catalog# 306-1811
SOAR Portal Tube Catalog# 304-1810
SOAR Beveled Portal Tube Catalog# 306-1806
SOAR Beveled Portal Tube Catalog# 306-1808
KI084/50
25-706/20
KI055/20
15022/50
323-01/20
19250/20
KN2415/10
15000/100
13-243/20
14-252/20
19960/10
KI160/50
MED27-736/20
19-350EFP/50
19240/25
15304/100
KI130/05
SP55/50
KI071/50
SOAR Portal Tube Catalog# 304-1504
15102S/100
HSC001/20
12-203K/20
KI031/50
19940/10
25-699/20
17525/25
560-755/01
SOAR Portal Tube Catalog# 304-1809
SOAR Portal Tube Catalog# 304-2211
SOAR Portal Tube Catalog# 304-2207
SOAR Beveled Portal Tube Catalog# 306-1809
SOAR Portal Tube Catalog# 304-1208
SP40/50
14-250/20
403-026-PK/20
24-708/20
27-734R/90
32-915/20
GS94-955/01
TOQ631
SOAR Beveled Portal Tube Catalog# 306-1511
SOAR Portal Tube Catalog# 304-2208
KI075/50
SOAR Portal Tube Catalog# 304-2609
18345/24
11-185SS/20
24-706/20
17435/20
KI025/20
17645/15
SOAR Portal Tube Catalog# 304-2206
SOAR Portal Tube Catalog# 304-2212
SOAR Portal Tube Catalog# 304-1506
15002/100
KI695/20
KI094/50
24-697/20
14-256S/20
16194/25
KIW91/50
SOAR Portal Tube Catalog# 304-1805
SOAR Portal Tube Catalog# 304-2607
17408/48
11-119S/20
25-717/20
KI118/100
MED27-750/20
19-362/20
KI1107/50
16-285LR/20
24-663/50
KI051/20
27-763A/20
KI072/20
02-447/20
KI035/50
KN2515/10
27-732/20
02-446/20
TD-6008/20
KI025/10
SOAR Portal Tube Catalog# 304-1808
SOAR Portal Tube Catalog# 304-2610
SOAR Portal Tube Catalog# 304-1812
SOAR Portal Tube Catalog# 304-1505
SOAR Beveled Portal Tube Catalog# 306-2210
SOAR Portal Tube Catalog# 304-2612
SOAR Beveled Portal Tube Catalog# 306-2206
15-274/20
19950/10
27-732R/60
15102/100
2110SA/25
27-736/20
EWST01/20
SOAR Portal Tube Catalog# 304-1804
SOAR Beveled Portal Tube Catalog# 306-1506
SOAR Beveled Portal Tube Catalog# 306-1512
SJM Leaflet Tester
Argyle Vascular Tourniquet Kit: 8888585000
SCALPEL, HEMOSTAT, NEEDLE HOLDER, SCISSOR, FORCEP
Anspach Bone Collector
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)