ETHICON, LLC

Registration Details

Registration Name: ETHICON, LLC
Registration Number: 3007791599
FEI Number: 3007791599
Status: Active
Expiry Year: 2026
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: K132580
PMA Number: N18331

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, Absorbable, Synthetic, Polyglycolic Acid	GAM	Class 2	General, Plastic Surgery	No	2015-05-19
Suture, Surgical, Absorbable, Polydioxanone	NEW	Class 2	General, Plastic Surgery	No	2019-01-14
Staple, Implantable	GDW	Class 2	General, Plastic Surgery	No	2013-02-13
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	Class 2	Cardiovascular	No	2014-07-21
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	Class 2	General, Plastic Surgery	No	2013-12-11
Device, Occlusion, Umbilical	FOD	Class 1	General Hospital	No	2014-07-14
Suture, Absorbable, Synthetic	GAN	Class 2	General, Plastic Surgery	No	2009-06-18
Laparoscope, General & Plastic Surgery	GCJ	Class 2	Gastroenterology, Urology	No	2014-03-19
Instrument, Surgical, Disposable	KDC	Class 1	General, Plastic Surgery	No	2013-08-16
Wax, Bone	MTJ	Class U	Unknown	No	2015-03-25
Cannula, Surgical, General & Plastic Surgery	GEA	Class 1	General, Plastic Surgery	No	2015-11-13
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	Class 2	General, Plastic Surgery	No	2017-11-03
Suture, Nonabsorbable, Silk	GAP	Class 2	General, Plastic Surgery	No	2009-06-18
Suture, Absorbable, Natural	GAL	Class 2	General, Plastic Surgery	No	2009-06-18
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	Class 2	General, Plastic Surgery	No	2009-06-18
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	Class 2	General, Plastic Surgery	No	2009-06-18

Proprietary Names

VICRYL PLUS STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device STRATAFIX Spiral PDS Plus Knotless Tissue Control Device SECURESTRAP Open Absorbable Strap Fixation Device TFE Polymer Pledgets MONOCRYL Plus Antibacterial Suture Coated VICRYL STRATAFIX Spiral MONOCRYL Plus Unidirectional Knotless Tissue Control Device PROLENE on TEFLON Pledget Buttress Coated VICRYL Plus PROLENE Polypropylene Suture Cotton Umbilical Tape MONOCRYL (dyed) CAPROFYL MONOCRYL Plus ETHICON ENDOSUTURE Holder ETHICON ENDOSUTURE SYSTEM VICRYL RAPIDE STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices Nylon Tape Mersilene Tape BONE WAX STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices Surgical Stainless Steel Suture PDS II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture VICRYL (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture Ethicon SECURESTRAP Absorbable Strap Fixation Device MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture Coated VICRYL Plus Antibacterial (Polyglactin 910) Absorbable Suture MONOCRYL (undyed) STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device PDS Plus Antibacterial Suture PDS II Suture STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device CHROMIC and PLAIN GUT ETHILON ETHIBOND STAINLESS STEEL MERSILK, SILK NUROLON MERSILENE, MERSUTURE PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Establishment Types

Manufacture Medical Device