FDA Registration
Active
🇺🇸 United States
Fiber, Medical, Absorbant
Reg #: 1058584
·
FEI: 1000219637
·
Expires 2025
Products
1
Proprietary Names
139
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1058584
- FEI Number
- 1000219637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10811 Withers Cove Park Drive
- City
- Charlotte
- State
- NC
- ZIP
- 28278
- 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 |
|---|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-11-15 |
Proprietary Names
Fiber, Medical, Absorbant
Medical Cotton Ball
B PLDL 1000 R00201 AC {APCS COTTON BALL LAR 2/1000}
8201/50
8250/50
8105/100
8305/100
4250/50
3044/24
10205/100
8205W/100
3264W/24
8418W/20
8023/50
3024/24
8014/50
8103/50
10105/100
8422/20
8415/50
8102/50
17460/20
8418/20
B PJDL 1000 R00201 US {USC COTTON BALL LG 1000/2}
8404/20
3034/24
B FMDLS 0130 R02406 LE {LEADER 24/130 STERILE BALL MED}
UMW001/50
3244/24
8461/50
8418/50
8402/20
8202/100
MED3034/24
8436W/25
8030W/05
8456/10
MED3124/24
8405/50
MED3244/24
3124/24
8105U/50
8401WNPP/05
4270/50
8201/100
8406W/10
8009/50
3544/20
8013/50
B FMDLS 0130 R03606 AHL {CAREONE STERILE CB MED 36/130}
8203/100
3164/24
MED3024/24
UMW002/50
WTL2025/25
3034K/24
MED3044/24
8436W/20
8412/20
MED3064/24
10110/100
8020/50
8215/100
8428/20
8413/50
3044K/24
8110/100
MED3234/24
3534/20
B PXDL 0500 R00401 US {USC COT BALL EXTRA LARGE 4/500}
B FMDLS 0130 R02406 FBB {FIRST AID 24/130 STER BALL MED}
B PMDL 2000 R00201 US {USC COTTON BALL MED 2/2000}
MED3224/24
MED3264/24
3024K/24
B PMDL 2000 R00201 FH {FISHER COT BALL MED 2/2000}
B FMDLS 0130 R02401 PB {PUBLIX STER CB MED 24/130}
8468/50
8416/20
8415/05
8011/50
4255/50
8101/100
8401/05
3524/20
8010/50
8401WH/05
3044W/24
8460W/10
3034W/24
3064K/24
8429W/20
8468/20
10120/50
MED3144/24
8022/50
4260/25
17440/20
B FMDLS 0130 R02401 HM {HEALTH MART STER CB MED 24/130}
8102/100
3234/24
B FMDLS 0130 R03606 TC {TOPCARE STER CB MED 36/130}
B FMDLS 0500 R01201 US {USC BL M COT STER 12/500 USC S}
8414/50
8440W/10
8469/10
8430/06
8420/20
8470/10
8106/50
8423/50
3264/24
8205/100
3064W/24
3224/24
8401W/05
3144/24
8401WN/05
8210/100
B FMDLS 0130 R02401 GD {GOODNEIGHBOR STE CB MED 24/130}
8441/50
8002/50
3134/24
B FMDLS 0130 R03606 TA {TGT STER CB 36/130 245-07-0577}
3064/24
B FMDLS 0130 R02401 SM {SUNMARK STER CB MED 24/130}
8465W/10
3564/20
MED303424/24
8408/20
3064/24S
B FMDLS 0130 R03601 WG {WALGREEN STERILE 36/130 340996}
8021/50
8204/50
8453W/50
16063/20
MED3164/24
4232/32
8462/50
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)