Medline Unite

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE UNITE FDA UDI
Generic Name: Orthopaedic bone screw starter/notcher FDA UDI
Device Name: DRILL BIT, SOLID CORE, AO/QC, 1.9MM FDA UDI
Model / Reference: MPN10019 FDA UDI
Description: DRILL BIT, SOLID CORE, AO/QC, 1.9MM FDA UDI

Identifiers

Catalog Number: MPN10019 FDA UDI
Primary DI / UDI-DI: 10888277690905 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Orthopaedic bone screw starter/notcher 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

FDA UDI

Over-the-Counter

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic bone screw starter/notcher

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

Similar devices

Also classified as Orthopaedic bone screw starter/notcher.

OsteoMed — Osteomed Corp. · Class II
ReLine — Nuvasive, Inc. · Class I
V. Mueller — STERIS CORPORATION · Class I
V. Mueller — STERIS CORPORATION · Class I
ReLine — Nuvasive, Inc. · Class I
Horizon Subtalar Gen 2 Sizing Probe 9mm — BIOPRO, INC. · Class I
Decima Spine Instrument Kit — DECIMA SPINE, INC. · Class I
AVATAR Minimally Invasive Spinal System — Life Spine, Inc. · 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI a1457bd6-2869-4020-8528-d752d77fce01 35 fields · synced May 31, 2026