Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Implantable cervical facet joint distractor FDA UDI
Device Name: DRILL BIT, SOLID CORE, 2.7MM FDA UDI
Model / Reference: MPN10027 FDA UDI
Description: DRILL BIT, SOLID CORE, 2.7MM FDA UDI

Identifiers

Catalog Number: MPN10027 FDA UDI
Primary DI / UDI-DI: 10888277719460 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Implantable cervical facet joint distractor 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

Yes

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: Implantable cervical facet joint distractor

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

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Also classified as Implantable cervical facet joint distractor.

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Disposable 5.5mm Drill Bit — SURGENTEC LLC · U
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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 91af7bfd-166e-4602-bf78-5815b472d8d4 35 fields · synced Jun 1, 2026