EndoLIF®

FDA UDI

Class II (US FDA UDI)

by Joimax, Inc.

Identity

Trade Name: EndoLIF® FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: EndoLIF® Instrument Tray FDA UDI
Model / Reference: EIT502550 FDA UDI
Description: EndoLIF® Instrument Tray FDA UDI

Identifiers

Primary DI / UDI-DI: 04250337107545 FDA UDI
510(k) Number: K151143 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

EndoLIF® by Joimax, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K151143 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: Joimax, Inc.

Sources (1)

FDA UDI bf069691-3d1e-4544-972b-1d9a20d65f98 35 fields · synced Jun 1, 2026