FDA Registration
Active
🇺🇸 United States
Puritan5503 (NR) - Sterile Foam Tipped Applicator
Reg #: 1720929
·
FEI: 1720929
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1720929
- FEI Number
- 1720929
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9120 SOUTH 150 EAST
- City
- Sandy
- State
- UT
- ZIP
- 84070
- Country
- US
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 |
|---|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2012-11-14 |
Proprietary Names
Puritan5503 (NR) - Sterile Foam Tipped Applicator
MML1375 (SN) - MML Specimen Collection Swab
SteriPackUSA7760 (GR,SP) - Sterile Flocked Swab
SteriPackUSA7760 (GR,SP) - SteriPack Sterile Polyester Spun Swab
Birchwood1772 (MN) - Scopettes JR
Puritan5503 (NR) - CaligSwab; HydraFlock; PurFlock Ultra; Puritan, Pur-Wraps; PurSwab
Puritan5503 (NR) - Puritan, Sterile Polyester Tipped Applicators
SteriPackUSA7760 (LN,SP) - Sterile 3" Foam Swab with yellow handle v2
SteriPackUSA7760 (SP) - Sterile Foam Swab with yellow handle
Robling1585 (SP) - ClearTip Swab Ultra Thin
Puritan5503 (NR) - Hospital, Sterile Cotton Tipped Applicators
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)