Neurolac

FDA UDI

Class II (US FDA UDI)

by Polyganics Innovations B.V.

Identity

Trade Name: Neurolac FDA UDI
Generic Name: Nerve guide, synthetic polymer, bioabsorbable FDA UDI
Model / Reference: 7.0 mm FDA UDI

Identifiers

Catalog Number: NG01-070/03 FDA UDI
Primary DI / UDI-DI: 08717703990164 FDA UDI
510(k) Number: K050573 FDA UDI
FDA Product Code: JXI FDA UDI
GMDN Term: Nerve guide, synthetic polymer, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5275 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: Lumen/Inner Diameter — 7 Millimeter FDA UDI

Category: Nerve guide, synthetic polymer, bioabsorbable

Neurolac by Polyganics Innovations B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve guide, synthetic polymer, bioabsorbable.

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COAPTIUM® Connect — Tissium SA · Class II
COAPTIUM® Connect — Tissium SA · Class II
Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. · Class II
Neurotube — SYNOVIS MICRO COMPANIES ALLIANCE, INC · Class II
allay™ Nerve Cap - Large Nerve Set — TULAVI THERAPEUTICS · Class II

Cleared under the same submission

K050573 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Polyganics Innovations B.V.

Sources (1)

FDA UDI 6793d6f4-6438-434e-b59e-0e58a9153a1b 37 fields · synced Jun 8, 2026