FDA Registration
Active
🇺🇸 United States
StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Medium
Reg #: 1047843
·
FEI: 1047843
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1047843
- FEI Number
- 1047843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2072 SOUTHPORT RD., HWY. 295
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29306
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012403
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2016-09-14 |
Proprietary Names
StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Medium
StrykerSustainability (SP) - enaFlow Foam Calf Cuff Dual Hose
StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Medium
StrykerSustainability (SP) - VenaFlow Elite Foot Garment Single Hose
StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Large
StrykerSustainability (SP) - Venaflow Elite Foam Calf Cuff Green
StrykerSustainability (SP) - Plexipulse Foot Wrap
StrykerSustainability (SP) - Venaflow Elite Calf Cuff Single Hose
StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Bariatric
StrykerSustainability (SP) - VenaFlow Elite Thigh Cuff Single Hose
StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Small
StrykerSustainability (SP) - Venaflow Elite XL Calf Cuff Single Hose
StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Large
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)