Full Face Sim Model - Patient-specific, full-face 3D printed anatomic - Mirrorme3d, LLC

Duns Number:060396278

Device Description: Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Full Face Sim Model

Version/Model Number

FFS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212981

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

b1cc39d9-f266-4bf8-80a5-671f5abe8fb7

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIRRORME3D, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 6