PROcedure Rehearsal Studio PROcedure Rehearsal Studio

GUDID 00816847021371

Radiology DICOM image processing application software

Primary Device ID	00816847021371
NIH Device Record Key	77bf4113-8648-4da3-b316-89e0f9af50f7
Commercial Distribution Status	In Commercial Distribution
Brand Name	PROcedure Rehearsal Studio
Version Model Number	2.0.1.
Catalog Number	PROcedure Rehearsal Studio
Company DUNS	085049749
Company Name	3D SYSTEMS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
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	00816847021371 [Primary]

LLZ	System, Image Processing, Radiological

Steralize Prior To Use	false
Device Is Sterile	false

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00816847022651 - Salto Talaris Chamfer Cut Total Ankle System	2024-09-20 A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the s
00816847022675 - VSP PEEK	2024-09-20 to fill a bony void or defect area in the cranial skeleton of patients
00816847022699 - Salto Talaris Chamfer Cut Total Ankle System	2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
00816847022705 - Salto Talaris Chamfer Cut Total Ankle System	2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
00816847022712 - Cadence Chamfer Cut Total Ankle System	2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
00816847022729 - Cadence Chamfer Cut Total Ankle System	2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
00816847022798 - Vantage 3D PSI	2024-08-13 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an

Mark Image Registration \| Serial	Company Trademark Application Date
PROCEDURE REHEARSAL STUDIO 77566372 3797749 Live/Registered	3D SYSTEMS, INC. 2008-09-10