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Treatment Plan Rhinoplasty Model

FDA UDI

Class II (US FDA UDI)

by Mirrorme3D, LLC

Identity

Trade Name
Treatment Plan Rhinoplasty Model FDA UDI
Generic Name
Custom-made organ/bone anatomy model FDA UDI
Device Name
Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only. FDA UDI
Model / Reference
MRCS FDA UDI
Description
Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only. FDA UDI

Identifiers

Primary DI / UDI-DI
00860008704160 FDA UDI
510(k) Number
K212981 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Custom-made organ/bone anatomy model

Treatment Plan Rhinoplasty Model by Mirrorme3D, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made organ/bone anatomy model.

Cleared under the same submission

K212981 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mirrorme3D, LLC

Sources (1)

  • FDA UDI a8f2f92d-18f1-431b-81d4-c858988ae884 34 fields · synced May 30, 2026