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Flap Marking Template

FDA UDI

Class I (US FDA UDI)

by Mirrorme3D, LLC

Identity

Trade Name
Flap Marking Template FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic. FDA UDI
Model / Reference
MFFT FDA UDI
Description
Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic. FDA UDI

Identifiers

Primary DI / UDI-DI
00860009784925 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 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

Yes

FDA UDI

Lot / Batch Number

No

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: Custom-made orthopaedic/craniofacial surgical guide

Flap Marking Template by Mirrorme3D, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mirrorme3D, LLC

Sources (1)

  • FDA UDI 2d1bd1f6-0293-44a2-8de5-1c4ea156a42e 33 fields · synced May 31, 2026