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Optivisc

FDA UDI

Class III (US FDA UDI)

by Anika Therapeutics, Inc.

Identity

Trade Name
Optivisc FDA UDI
Generic Name
Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
Device Name
0.8 mL, 12 mg/mL Sodium Hyaluronate FDA UDI
Model / Reference
600-105 FDA UDI
Description
0.8 mL, 12 mg/mL Sodium Hyaluronate FDA UDI

Identifiers

Primary DI / UDI-DI
00866142000038 FDA UDI
PMA Number
P000046 FDA UDI
FDA Product Code
LZP FDA UDI
GMDN Term
Vitreous/aqueous humour replacement medium, intraoperative FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.4275 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vitreous/aqueous humour replacement medium, intraoperative

Optivisc by Anika Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitreous/aqueous humour replacement medium, intraoperative.

Cleared under the same submission

P000046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anika Therapeutics, Inc.

Sources (1)

  • FDA UDI cfe035b4-1754-4e0e-888c-f48f8b343c8e 34 fields · synced Jun 9, 2026