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Polyaxial Drill Guide

FDA UDI

Class II (US FDA UDI)

by Miami Device Solutions

Identity

Trade Name
Polyaxial Drill Guide FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Polyaxial Drill Guide, 2.7T FDA UDI
Model / Reference
MDS100816 FDA UDI
Description
Polyaxial Drill Guide, 2.7T FDA UDI

Identifiers

Catalog Number
MDS100816 FDA UDI
Primary DI / UDI-DI
10812269021965 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusableInternal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Polyaxial Drill Guide by Miami Device Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Miami Device Solutions

Sources (1)

  • FDA UDI 8c26e49c-eed4-4393-bfb2-408983ac5623 35 fields · synced May 30, 2026