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IMPIX 3D Print

FDA UDI

Class I (US FDA UDI)

by Medicrea International SA

Identity

Trade Name
IMPIX 3D Print FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Implant remover FDA UDI
Model / Reference
A24200200 FDA UDI
Description
Implant remover FDA UDI

Identifiers

Primary DI / UDI-DI
03613720281627 FDA UDI
510(k) Number
K163595 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, 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

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: Orthopaedic inorganic implant inserter/extractor, reusable

IMPIX 3D Print by Medicrea International SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Cleared under the same submission

K163595 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medicrea International SA

Sources (1)

  • FDA UDI df317315-9104-4562-85b8-be864ed83c59 34 fields · synced May 30, 2026