Morphix XT

FDA UDI

Class I (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name: Morphix XT FDA UDI
Generic Name: Surgical drill guide, single-use FDA UDI
Device Name: Single Use Drill and Guide Procedure Pack, Sterile, 2.5mm FDA UDI
Model / Reference: 1000-10-025 FDA UDI
Description: Single Use Drill and Guide Procedure Pack, Sterile, 2.5mm FDA UDI

Identifiers

Primary DI / UDI-DI: M9701000100250 FDA UDI
FDA Product Code: HTW FDA UDI
KDD FDA UDI
GMDN Term: Surgical drill guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cannulated surgical drill bit, single-use Surgical drill guide, single-use

Morphix XT by Medshape, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Medshape, Inc.

Sources (1)

FDA UDI 3541683a-5b4c-47a0-977e-90f4e3da127d 33 fields · synced May 30, 2026