FDA Registration
Active
🇺🇸 United States
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Reg #: 3007791599
·
FEI: 3007791599
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ETHICON, LLC
- Registration Number
- 3007791599
- FEI Number
- 3007791599
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 475 C Street, Los Frailes Industrial Park, Suite 401
- City
- Guaynabo
- State
- PR
- ZIP
- 00969
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212380
Owner / Operator
- Firm Name
- ETHICON, LLC
- Operator Number
- 10029715
- Address
- 475 C Street, Los Frailes Industrial Park, Suite 401
- City
- Guaynabo
- State
- PR
- Postal Code
- 00969
- Country
- US
- Correspondent
- Reynaldo Librojo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2022-03-08 |
Proprietary Names
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Establishment Types
Manufacture Medical Device