Synvisc

FDA UDI

Class III (US FDA UDI)

by Saima Global Farma S.l.

Identity

Trade Name: SYNVISC FDA UDI
Generic Name: Synovial fluid supplementation medium FDA UDI
Device Name: SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. FDA UDI
Model / Reference: 58468-0090-1 FDA UDI
Description: SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. FDA UDI

Identifiers

Primary DI / UDI-DI: 08437027710056 FDA UDI
PMA Number: P940015 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Category: Synovial fluid supplementation medium

Synvisc by Saima Global Farma S.l. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synovial fluid supplementation medium.

Euflexxa — ACRE PHARMA LIMITED · Class III
Gel-One® Cross-linked Hyaluronate — Seikagaku Corp. · Class III
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack — Fidia Farmaceutici · 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
Euflexxa — PAVAN TRADING LTD · Class III

Cleared under the same submission

P940015 also covers:

Synvisc — ALLY MEDICAL SUPPLIES LTD
Synvisc One — ALLY MEDICAL SUPPLIES LTD
Synvisc-One® — Genzyme Corp.
Synvisc® — Genzyme Corp.
Synvisc One (Synvisc Three) — PAVAN TRADING LTD
SYNVISC ONE — SAIMA GLOBAL FARMA S.L.

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: Saima Global Farma S.l.

Sources (1)

FDA UDI 6afcafc9-8155-4c34-b63c-daf1ef99d538 35 fields · synced May 31, 2026