Gelsyn-3

FDA UDI

Class III (US FDA UDI)

by Ibsa Farmaceutici Italia Srl

Identity

Trade Name: GELSYN-3 FDA UDI
Generic Name: Synovial fluid supplementation medium FDA UDI
Device Name: INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT FDA UDI
Model / Reference: GS3111 FDA UDI
Description: INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT FDA UDI

Identifiers

Primary DI / UDI-DI: 08033638951057 FDA UDI
FDA Product Code: MOZ FDA UDI
GMDN Term: Synovial fluid supplementation medium FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 2.25 Milliliter FDA UDI

Category: Synovial fluid supplementation medium

Gelsyn-3 by Ibsa Farmaceutici Italia Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ORTHOVISC — SAIMA GLOBAL FARMA S.L. · Class III
Supartz — PAVAN TRADING LTD · Class III
Supartz — Arcera GmbH · Class III
VISCO-3 sodium hyaluronate — Seikagaku Corp. · Class III
Synvisc One (Synvisc Three) — PAVAN TRADING LTD · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Ibsa Farmaceutici Italia Srl

Sources (1)

FDA UDI 7f58a728-9b07-450d-a1b7-ee034f77e9c4 36 fields · synced May 30, 2026