FDA Registration Active 🇺🇸 United States

StrykerSustainability (SP) - Hemo-Force Calf Garment Medium

Reg #: 1047843 · FEI: 1047843 · Expires 2025
Products
1
Proprietary Names
8
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
K060091

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
Sleeve, Limb, Compressible JOW

Proprietary Names

StrykerSustainability (SP) - Hemo-Force Calf Garment Medium StrykerSustainability (SP) - Hemo-Force Thigh Garment Large StrykerSustainability (SP) - Hemo-Force Calf Garment Bariatric StrykerSustainability (SP) - Hemo-Force Calf Garment Small StrykerSustainability (SP) - Hemo-Force Thigh Garment Medium StrykerSustainability (SP) - Hemo-Force Calf Garment Large StrykerSustainability (SP) - Vaso/Hemo Force Foot Garment Large StrykerSustainability (SP) - Vaso/Hemo Force Foot Garment Medium

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)