FDA Registration
Active
🇺🇸 United States
Hollister (SP) - Clamp, Umbilical-Umbilical Cord Clamp
Reg #: 1047843
·
FEI: 1047843
·
Expires 2025
Products
1
Proprietary Names
3
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
- K781548
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 |
|---|---|---|---|---|---|
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2019-12-30 |
Proprietary Names
Hollister (SP) - Clamp, Umbilical-Umbilical Cord Clamp
Hollister (SP) - AMNIHOOK AMNIOTIC; U-BAG URINE SPECIMEN COLLECTOR; Plastibell; Umbilical Cord Clamp
Hollister (SP) -Clamp, Umbilical
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)