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Biolon

FDA UDI

Class III (US FDA UDI)

by Altacor , Ltd.

Identity

Trade Name
Biolon FDA UDI
Generic Name
Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
Device Name
Viscoelastic surgical aid FDA UDI
Model / Reference
version 1 FDA UDI
Description
Viscoelastic surgical aid FDA UDI

Identifiers

Catalog Number
62501 FDA UDI
Primary DI / UDI-DI
15060156070373 FDA UDI
PMA Number
P960011 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Total Volume — 1 Milliliter FDA UDI

Category: Vitreous/aqueous humour replacement medium, intraoperative

Biolon by Altacor , Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Altacor , Ltd.

Sources (1)

  • FDA UDI 96541455-637c-416e-b750-b0949f2fbf6a 38 fields · synced May 31, 2026