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
Suture Kit OVN

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)