Splint LT Kit

GUDID 00860008704191

Patient specific, 3D printed, single use postoperative nasal splints to control edema based a patient’s treatment plan. RX only, non-diagnostic.

Mirrorme3d, LLC

External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint
Primary Device ID00860008704191
NIH Device Record Keybb3dfc9f-5af7-4938-a869-9bb44375c502
Commercial Distribution StatusIn Commercial Distribution
Brand NameSplint LT Kit
Version Model NumberMSTL
Company DUNS060396278
Company NameMirrorme3d, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008704191 [Primary]

FDA Product Code

EPPSplint, Nasal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

Devices Manufactured by Mirrorme3d, LLC

00860009784925 - Flap Marking Template2023-03-27 Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan.
00860009784901 - Guide2023-02-24 Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnost
00860009784918 - Template2023-02-24 Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX o
00196852129638 - Template2022-10-11 Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX o
00196852441754 - Guide2022-10-11 Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnost
00860008704139 - Full Face Baseline Model2022-10-11 Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. R
00860008704146 - Full Face Sim Model2022-10-11 Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
00860008704153 - Baseline Rhinoplasty Model2022-10-11 Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.