Primary Device ID | 00860009784925 |
NIH Device Record Key | 2d1bd1f6-0293-44a2-8de5-1c4ea156a42e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Flap Marking Template |
Version Model Number | MFFT |
Company DUNS | 060396278 |
Company Name | Mirrorme3d, LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860009784925 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
[00860009784925]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-03-27 |
Device Publish Date | 2023-03-17 |
00860009784925 - Flap Marking Template | 2023-03-27Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic. |
00860009784925 - Flap Marking Template | 2023-03-27 Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan. |
00860009784901 - Guide | 2023-02-24 Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnost |
00860009784918 - Template | 2023-02-24 Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX o |
00196852129638 - Template | 2022-10-11 Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX o |
00196852441754 - Guide | 2022-10-11 Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnost |
00860008704139 - Full Face Baseline Model | 2022-10-11 Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. R |
00860008704146 - Full Face Sim Model | 2022-10-11 Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only. |
00860008704153 - Baseline Rhinoplasty Model | 2022-10-11 Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic |