FDA Registration
Active
🇺🇸 United States
PURITAN MEDICAL PRODUCTS COMPANY LLC
Reg #: 1216735
·
FEI: 1216735
·
Expires 2026
Products
14
Proprietary Names
15
Establishment Types
4
Classifications
14
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Registration Details
- Registration Name
- PURITAN MEDICAL PRODUCTS COMPANY LLC
- Registration Number
- 1216735
- FEI Number
- 1216735
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 31 School St
- City
- GUILFORD
- State
- ME
- ZIP
- 04443
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242820
Owner / Operator
- Firm Name
- HARDWOOD PRODUCTS COMPANY LP
- Operator Number
- 1216735
- Address
- 31 SCHOOL ST., P.O. BOX 149
- City
- Guilford
- State
- ME
- Postal Code
- 04443
- Country
- US
- Correspondent
- Kevin Wrigley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2017-10-21 |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2026-01-19 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2012-03-06 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2012-03-06 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2023-03-31 |
| Transport Systems, Anaerobic | JTX | Class 1 | Microbiology | No | 2013-11-01 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2013-11-01 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2010-06-22 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1978-03-23 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 1978-03-23 |
| Culture Media, Selective And Non-Differential | JSJ | Class 1 | Microbiology | No | 2023-03-31 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2012-04-17 |
| Culture Media, Enriched | KZI | Class 1 | Microbiology | No | 2023-03-31 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-04-24 |
Proprietary Names
Puritan Medical Products Company LLC
PureSafe Plus
Puritan
Opti-Tranz
Opti-Swab
HydraFlock
PurSwab
PurFlock Ultra
CaligSwab
Puritan, Pur-Wraps
Brightwood
Hospital
Puritan Histobrush
Puritan Fecal Opti-swab Collection and Transport ystem
Puritan DM Stick
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device