IBSA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008280916	3008280916	IBSA Farmaceutici Italia Srl	1	N	2026-01-01	Via Martiri di Cefalonia 2 Lodi (San Grato) Lombardy IT 26900

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
08033638951057	GELSYN-3 - INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT	1-800-836-4080	info@ibsa.it
08033638951057	GELSYN-3 - INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT	1-800-836-4080	CustomerServiceUSA@bioventusglobal.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
192422	2053545629	P110005	SINOVIAL (SODIUM HYALURONATE 0.8%)	MOZ	2014-05-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MOZ	2	2014-05-09

NDC#

PMA#

IBSA INSTITUT BIOCHIMIQUE SAvia Al Ponte 13, Ch-6903lugano Ticino 6903 PMA NumberP110005 Supplement NumberS012 Date Received09/08/2022 Decision Date10/07/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplemen...

GELSYN-3

2022-03-18

IBSA INSTITUT BIOCHIMIQUE SAvia Al Ponte 13, Ch-6903lugano Ticino 6903 PMA NumberP110005 Supplement NumberS011 Date Received02/16/2022 Decision Date03/18/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Pro...

Applications#

210858

IBSA

206976

IBSA INST BIO

GUDID#

GELSYN-3 - INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT

IBSA FARMACEUTICI ITALIA SRL

2016-07-25