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Splint LT Kit

Mirrorme3d, LLC · Model MSTL · UDI-DI 00860008704191

EPP Prescription
10
510(k) clearances
19
Adverse events
2
Recalls
38
Facilities

Description

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

Recalls

DateFirmReason
2011-02-21Medtronic Xomed, Inc.Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 152812
2011-02-21Medtronic Xomed, Inc.Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 152812

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.