Mirrorme3d, LLC

Address:222 West 37th Street,New York,NY,10018,US

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Premarket Exempt
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- Catalog Number :

Device Description : Patient specific, 3D printed, single use surgical marking template based a pati Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic.

Device Class : 1

Duns Number: 060396278

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Patient specific, 3D printed, single-use surgical positioning guide based on a p Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnostic.

Device Class : 1

Duns Number: 060396278

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Device Description : Patient-specific, full-face 3D printed anatomic model depicting a patient’s base Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.

Device Class : 2

Duns Number: 060396278

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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

Device Class : 2

Duns Number: 060396278

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : Patient-specific, partial face 3D printed anatomic model depicting a patient’s b Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.

Device Class : 2

Duns Number: 060396278

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : Patient-specific, partial-face 3D printed anatomic model depicting a patient’s t Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.

Device Class : 2

Duns Number: 060396278

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : Patient-specific, partial face 3D printed anatomic model depicting a patient’s b Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.

Device Class : 2

Duns Number: 060396278

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : Patient-specific, partial-face 3D printed anatomic model depicting a patient’s t Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only

Device Class : 2

Duns Number: 060396278

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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

Device Class : 1

Duns Number: 060396278

Premarket Exempt : Yes

Product Code : EPP

Prescription Use : Yes

Device Count : 1