Medline UNITE

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline UNITE FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: WASHER, USE WITH 3.0MM, 3.5MM SCREWS FDA UDI
Model / Reference: MSW03035 FDA UDI
Description: WASHER, USE WITH 3.0MM, 3.5MM SCREWS FDA UDI

Identifiers

Catalog Number: MSW03035 FDA UDI
Primary DI / UDI-DI: 10884389957424 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Implantable bone washer

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

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Also classified as Implantable bone washer.

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Monster Screw System — Paragon 28 · Class II
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Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · Class II

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: Medline Industries, Inc.

Sources (1)

FDA UDI 57df6f18-56c9-477e-8572-534611db099e 36 fields · synced Jun 8, 2026