Synvisc-One®

FDA UDI

Class III (US FDA UDI)

by Genzyme Corp.

Identity

Trade Name: Synvisc-One® FDA UDI
Generic Name: Synovial fluid supplementation medium FDA UDI
Device Name: Acid, Hyaluronic, Intraarticular FDA UDI
Model / Reference: 002401 FDA UDI
Description: Acid, Hyaluronic, Intraarticular FDA UDI

Identifiers

Primary DI / UDI-DI: 20358468019114 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

Dimensions & Sizes

Size: Total Volume — 6 Milliliter FDA UDI

Category: Synovial fluid supplementation medium

Synvisc-One® by Genzyme Corp. — 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
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

Cleared under the same submission

P940015 also covers:

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

Sources (1)

FDA UDI be653c1a-a962-43aa-bfcd-6da7ad2dc7e3 37 fields · synced Jun 6, 2026