Medlineunite

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINEUNITE FDA UDI
Generic Name: Surgical depth gauge, single-use FDA UDI
Device Name: SLEEVE, DRILL BIT FOR 6.5/7.0 SCREWS FDA UDI
Model / Reference: MSN40006 FDA UDI
Description: SLEEVE, DRILL BIT FOR 6.5/7.0 SCREWS FDA UDI

Identifiers

Catalog Number: MSN40006 FDA UDI
Primary DI / UDI-DI: 10884389957301 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical depth gauge, single-use 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

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

Yes

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: Surgical depth gauge, single-use

Medlineunite by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical depth gauge, single-use.

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Solanas — ALPHATEC SPINE, INC. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
FuzeFix Mini — FUSION ORTHOPEDICS, LLC · 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: Medline Industries, Inc.

Sources (1)

FDA UDI 07fe1e32-9bc4-4df0-954c-77971c6ac5e0 35 fields · synced May 31, 2026