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Charlotte

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
CHARLOTTE FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Lisfranc Drill Sleeve FDA UDI
Model / Reference
43510145 FDA UDI
Description
Lisfranc Drill Sleeve FDA UDI

Identifiers

Catalog Number
43510145 FDA UDI
Primary DI / UDI-DI
00889797012294 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical drill guide, reusable 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

The CHARLOTTE surgical drill guide is a reusable, manual surgical device designed for simultaneous placement, angling, and guiding of rotating surgical drills on hard tissue. Made from metal, it features graduations along its length and may have serrations to enable firm placement. This device allows protection of surrounding soft tissue during surgery, is typically made in tubular form with guiding holes, and can be used without customizing for a specific patient.

Similar devices

Also classified as Surgical drill guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wright Medical Technology, Inc.

Sources (1)

  • FDA UDI f3c8edcc-20d8-4547-8682-092f4d4beb67 36 fields · synced Jul 10, 2026