FDA Registration
Active
🇺🇸 United States
DEKNATEL
Reg #: 1061124
·
FEI: 1000512168
·
Expires 2025
Products
1
Proprietary Names
181
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1061124
- FEI Number
- 1000512168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10821 Withers Cove Park Dr
- 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 |
|---|---|---|---|---|---|
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2013-08-23 |
Proprietary Names
DEKNATEL
VPAK (XG69-7101GWM10)X2
V-PAK (6-774)X5 (X6-774W)X5
V-PAK (XC7-7044GWM10)X1
V-PAK (XH6-7044GW)X10
V-PAK (XG79-420GWM8)X2
V-PAK ASST SUTURES X10
V-PAK (XG6-7037GW)X10
V-PAK (X69-723GWM8)X2
V-PAK (X79-414GWM8)x1
VPAK(XG7-7080GWM8)X2
V-PAK (XB7-798)X15
V-PAK (7-7044)X5 (X7-7044W)X5
V-PAK (X79-717M10)
V-PAK (X-6315GWM8)X2
V-PAK ASSTD SUTURE X5
V-PAK (G69-424GW)X10
V-PAK (X-6078)X5 (X-6078W)X5
VPAK (X-7080) X 4 (X-7080W) X 4
V-PAK (7-7037M8) X2
V-PAK (XG6-420GWM10) X2
V-PAK (XF7-798) X 10 (XF7-798W) X 10
V-PAK (XB6-420GWM8)X2
V-PAK (X6-797GWM10)X2
V-PAK DR JOHNSON
V-PAK (7-774)X5 (X7-774W)X5
V-PAK (XF7-774GW)X10
V-PAK (6-7027GWM10) X2
V-PAK (X-6201GWM8)X1 (X-6202M8)X1
V-PAK (B7-6686) X 10 (B7-6686W) X 10
Suture kit
V-PAK (X79-7027GWM8)X2
V-PAK (XG7-774GWM8)X2
V-PAK (B7-7101GW)X10
V-PAK (B7-7037)X15
V-PAK ASSTD SUTURES X11
V-PAK (X7-7037W)X5 (7-7037)X5
V-PAK (XH7-774)X10
V-PACK ASSORTED SUTURE X48
V-PAK (XB7-7027M8) X2
V-PAK (79-733)X5 (79-733W)X5
V-PAK (X-6025)X5 (X-6025W)X5
V-PAK (G6-7101GW)X10
V-PAK (H7-420)X4 (XH7-420W)X4
V-PAK (X-4884)X6
V-PAK (B7-774)X5 (XB7-774W)X5
V-PAK (X79-774W)X5 (79-774)X5
V-PAK (X6-420GWM8)X2
V-PAK B79-420 X5 XB79-420W
V-PAK (69-717GW)X10
V-PAK (G6-774)X5 (XG6-774W)X5
V-PAK (H7-420)X5 (XH7-420W)X5
V-PAK (B7-7037)X5(XB7-7037W)X5
V-PAK (X-4257GW)X10
V-PAK DR BROWN
V-PAK (X-4948M10) X1 0012 PER BOX
V-PAK (X-5460GWM10) X1
V-PAK (7-420)X5 (X7-420W)X5
V-PAK (XC7-7045)X5 (XC7-7045W)X5
V-PAK (G69-717GW)X10
V-PAK (XB79-717W)X5 (B79-7 17)X5
V-PAK (X-6489GWM8)X2
V-PAK (G6-420)X3 (G6-420W)X3
V-PAK (XG6-723W)X5 (G6-723)X5
V-PAK (XB79-7027GWM6) X2
V-PAK (X-2914W)X3 (X-2357)X3
V-PAK DR HARVEY
V-PAK (XB6-7038GW)X8
V-PAK (XG79-774GW)X10
V-PAK (X-5576A)X4 (X-5576WA)X4
V-PAK ASSTD SUTURES
V-PAK (G7-774)X5
V-PAK (XH79-799G)X4 (XH79-799W)X4
V-PAK (X7-7039W)X5 (X7-7039)X5
V-PAK (X-5881)X10 (X-5881W)X10
V-PAK (XH7-774)X5 (XH7-774W)X5
V-PAK (XG69-7101GWM8)X2
V-PAK (79-797)X5 (X79-797W)X5
V-PAK (XG69-7038GW)X10
V-PAK (XB79-774GW)X10
V-PAK (XG7-7039)X6 (&WH)X5
V-PAK (XB69-7037GWM8)X2
V-PAK ASSTD SUTURES X8
V-PAK (X6-7037)X5 (X6-7037W)X5
V-PAK TEV GW 2-0 KC-2 2N 30" X10
V-PAK DR RIZZONI
V-PAK (H69-774)X5 (XH69-774W)X5
V-PAK (79-716)X5 (X79-716W)X5
V-PAK (7-774)X5
V-PAK (X7-774GWM8)X2
V-PAK (B69-717W)X3 (B69-717)X3
V-PAK (X-4529)X4 (4529W)X4
V-PAK (X-6020)X5 (X-6020W)X5
V-PAK (6-7101GWM8)X2
V-PAK (F69-717) X5 (F69-717W)X5
V-PAK (B79-774GWM10)X1
V-PAK XF79-7027GW X10
V-PAK (XG69-420GWM8)X2
V-PAK (X6-723GWM8)X2
V-PAK (S-894)X10
V-PAK (C6-420GW)X10
V-PAK (X-6439)X12
V-PAK (7-420)X5
V-PAK (X6-420W)X3 (6-420)X3
V-PAK(X-5576B)X4 (X-5576WB)X4
V-PAK (G7-420GW)X10
V-PAK (B69-420GW)X10
V-PAK (B7-7040)X5 (B7-7040W)X5
V-PAK (XH7-420GWM8)X2
V-PAK POL 2-0 KC-2 2N 30"X10
V-PAK (X-6473)X15 (X-6473W)X15
V-PAK (X7-420GWM8)X2
V-PAK (XG69-7027)X5 (XG69-7027W)X5
V-PAK (G7-7027)X4 (G7-7027W)X4
VPAK (7-7027GWM8)X2
V-PAK (XG6-420GWM8)X2
V-PAK (G79-420)X5 (XG79-420W)X5
V-PAK (XH7-6770) X 5 (XH7-6770w) X 5
ARMC CANNULATION PACK
V-PAK (XHP-1290GW)X10
V-PAK (G7-774GW)X10
V-PAK (X-7101GWM8) X2
V-PAK (XG79-7027GWM8)X2
V-PAK (XB79-774GWM8)X2
V-PAK (XH7-6770) X 4 (XH7-6770W) X 4
V-PAK POL GW 2-0 C-2 2N 30" X10
V-PAK (X-5154)X10
V-PAK (79-799)X10
V-PAK (X-6021)X5 (X-6021W)X5
V-PAK ASSTD SUTURES X 40
V-PAK (G7-774)X3 (XG7-774W)X3
V-PAK (XG7-7080)X5
V-PAK ASSTD SUTURES X10
V-PAK (X-4948GWM10)X1
V-PAK (G69-7101)X5 (G69-7101W)X5
V-PAK ASSTD SUTURES X20
V-PAK (7-797)X5
V-PAK (G79-717)X4 (XG79-717W)X4
V-PAK (H6-420GW)X10
V-PAK (X7-6803GWM7)X1 (X7-6803GWM8)X1
V-PAK (X79-7101GW)X10
V-PAK (X-4967)X6
V-PAK (G6-7101GWM8)X2
CABG KIT
V-PAK (C6-774)X5 (XC6-774W)X5
V-PAK (X-6023)X5 (X-6023W)X5
V-PAK (XB79-7027W)X5 (XB-79-7027W)X5
V-PAK (XB79-7072GWM8) X2
V-PAK (X79-774GWM8)X2
V-PAK (79-717GW)X10
V-PAK (X-6740)X5 (X-6740W) X5
V-PAK (XF-6020) X5 (XF-6020W) X5
V-PAK (B69-774GW)X10
V-PAK (X79-7027GWM8) X1
V-PAK (X-6744)X4 (X-6744W)X4
DR LYNN-MITRAL VALVE REPAIR
V-PAK (G69-774)X5 (XG69-774W)X5
V-PAK (G7-7044)X5 (G7-7044W)X5
RC TIE PAK TEV X2 SLK X2
V-PAK (XB-5670)X4 (XB-5670W)X4
V-PAK (G7-774)X10
V-PAK (7-760) X5 (7-760W) X5
V-PAK (B7-420)X5 (XB7-420W)X5
V-PAK (X-6802) X 7 (X-6802W) X 7
V-PAK (X-6747)X10 (GFS-10A)X1
V-PAK (XG79-7027GW)X8
RC TIE PAK TEV X1 SLK X2
V-PAK (X69-7037GWM8)X2 X69-7037GWM4)X1
V-PAK (XRN-5787)X8
V-PK (B6-420GW)X10
V-PAK (G79-717) (XG79-717W)X10
VPAK (XB79-420GWM8)X2
V-PAK (C69-723GWM8)X2
V-PAK (X-6697GW)X10
V-PAK (XRN-5692)X8
V-PAK (XG79-7027GW)X10
V-PAK(F6-7044GWM8)x2
V-PAK (B69-717)X5 (B69-717W)X5
V-PAK (XB7-797W)X5 B7-797X5)
V-PAK (F6-774)X4 (XF6-774W)X4
LACERATION KIT
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)