FDA Registration
Active
🇺🇸 United States
PLED SOFT 1/4"X3/16"X1/16" X12
Reg #: 1018470
·
FEI: 1018470
·
Expires 2025
Products
1
Proprietary Names
55
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1018470
- FEI Number
- 1018470
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2971 Olympic Industrial Dr SE Ste 116
- City
- Atlanta
- State
- GA
- ZIP
- 30339
- 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 |
|---|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2018-01-11 |
Proprietary Names
PLED SOFT 1/4"X3/16"X1/16" X12
PLED SFT OVAL 3/8"X5/16" 10PK
PLED INT 1/2"X5/16"X1/16" X6
PLED SOFT 1/4"X3/16"X1/16" X5
PLED FIRM 5MMX3MM X1/16" X6
PLED OVAL SOFT 6MMX4.5MMX1/16"
PLED SOFT 6" X 1/2"
PLED SOFT 5/8"X3/8"X1/16" X6
PLED SOFT 3/4"X3/8"X1/16" X4
PLED SOFT 1/2"X5/16"X1/16" X6
PLED SOFT 7/8"X3/8"X1/16" X2
PLED SMALL FIRM 1/8"X1/8"X1/16"
PLED SOFT 8MMX8MMX1/16" X6
PLED SOFT LRG 3/8"X3/16"X1/16"
PLED SOFT 5/16"X5/16"X1/16" X4
PLED SOFT 6"X5/16"X1/16" X2
PLED SOFT 10MM X 7MM X 1.6MM
PLED SOFT 6"X5/16"X1/1
PLED 3/8"X3/16"X1/32"
PLED SOFT MED 1/4"X1/8"X1/16"
PLED SOFT 3/4"X5/16"X1/16" X2
PLED FIRM SMALL 1/8"X1/8"X1/16"
PLED SOFT 1/2"X1/4"X1/6 X4
PLED FIRM 1/8"X1/12"X1/16" X6
PLED INT 1/2"X6"X1/16" X1
PLED SOFT 4"X5/16"X1/16" X2
PLED FIRM MED 1/4"X1/8"X1/16"
PLED SOFT 3/8"X3/8"X1/16" X2
PLED SFT 5/8"X5/16"X1/16" X6
PLED SOFT 3" X6"
PLED INT 5/8"X3/8"X1/16" X6
PLED SOFT ROUND 6MM
PLED SOFT 1/2"X5/16"X1/16" X4
PLED SOFT 1"X1"X1/16"
PLED SOFT 1/2"X1/4"X1/16" X6
PLED INT 3/4"X3/8"X1/16" X6
PLED SOFT 3/4"X3/8"X1/16" X2
PLED INT 1/2"X4"X1/16" X1
PLED SOFT 1/4"X1/4"X1/16" X12
PLED SOFT 5/8"X3/8"X1/16" X5
PLED SOFT LG 3/8"X3/16"X1/16"
PLED SOFT 6"X1"X1/16"
PLED SPEC 5/8"X1/4"X1/16" X4
PLED SOFT 3/8"X3/8"X1/16" X8
PLED SOFT 3/4"X1/2"X1/16" X2
PLED SFT LARGE 6"X6"
PLED SOFT 3/4"X3/8"X1/16" X6
PLED SOFT 1/4"X1/4X1/16
PLED FIRM LARGE 3/8"X3/16"X1/16"
PLED SOFT 3/4"X5/16"X1/16" X6
PLED SOFT 1/4"X3/16"X1/16"
PLED SOFT 3"X3"X1/16"
PLED SOFT 7/8"X1/2"X1/16" X4
PLED FIRM 3/8"X1/8"X1/
PLED SOFT 1/4"X25/64"X1/16" X4
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)