FDA Registration
Active
🇺🇸 United States
Ethicon LLC
Reg #: 3032543753
·
FEI: 3032543753
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Ethicon LLC
- Registration Number
- 3032543753
- FEI Number
- 3032543753
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PR-2, Km 45.6
- City
- Alts de Manati
- State
- PR
- ZIP
- 00674
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133356
Owner / Operator
- Firm Name
- ETHICON INC.
- Operator Number
- 2210968
- Address
- 1000 US Highway 202 S.
- City
- Raritan
- State
- NJ
- Postal Code
- 08869
- Country
- US
- Correspondent
- Reynaldo Librojo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2013-12-11 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
Proprietary Names
PROLENE Polypropylene Nonabsorbable Suture
PERMA-HAND/Mersilk Suture/Silk Suture
ETHILON Nylon Suture
NUROLON
ETHIBOND
ETHIBOND EXCEL
SURGICAL GUT SUTURE (Plain and Chromic)
MERSILENE, MERSUTURE
Establishment Types
Manufacture Medical Device