FDA Registration Active 🇧🇪 Belgium

VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture

Reg #: 3014272734 · FEI: 3014272734 · Expires 2025
Products
2
Proprietary Names
3
Establishment Types
1
Classifications
2

Registration Details

Registration Name
GMED Healthcare BVBA ( a Johnson & Johnson Company)
Registration Number
3014272734
FEI Number
3014272734
Status
Active
Expiry Year
2025
Initial Importer
No
Address
European Distribution Centre, Rue du Luxembourg 5
City
Courcelles Luxembourg
Country
BE

Regulatory Submissions

510(k) Number
K183183

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

US Agent

Business Name
ETHICON Inc
Contact Name
Reynaldo Librojo
Address
1000 US Highway 202
City
Raritan
State
NJ
ZIP
08869
Country
US
Phone
908 8086028

Products

Device Name Product Code
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Surgical, Absorbable, Polydioxanone NEW

Proprietary Names

VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS™ II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Establishment Types

Export Device to the United States But Perform No Other Operation on Device