OptiLIF Endo, Direct Visualization System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name: OptiLIF Endo, Direct Visualization System FDA UDI
Generic Name: Endoscopic-access dilator, reusable FDA UDI
Device Name: TF Endo Tubular Retractor, 7.5mm x 163mm x Elevated Tip FDA UDI
Model / Reference: 05-01-24-5 FDA UDI
Description: TF Endo Tubular Retractor, 7.5mm x 163mm x Elevated Tip FDA UDI

Identifiers

Catalog Number: 105-0039 FDA UDI
Primary DI / UDI-DI: M7401050039 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Endoscopic-access dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Endoscopic-access dilator, reusable

OptiLIF Endo, Direct Visualization System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endoscopic-access dilator, reusable.

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iLESSYS® — JOIMAX, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I
TESSYS® — JOIMAX, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Spineology Inc.

Sources (1)

FDA UDI 5100e895-aa23-4eca-a7e4-33453d11a745 35 fields · synced Jun 1, 2026