Modus Nav Operator Cart

GUDID 00670082000528

Synaptive Medical Inc

Neurological stereotactic surgery system
Primary Device ID00670082000528
NIH Device Record Keyf1dd1ff4-7e93-47f8-a54b-06b4ab58685a
Commercial Distribution StatusIn Commercial Distribution
Brand NameModus Nav Operator Cart
Version Model NumberSYN-0982
Company DUNS203061833
Company NameSynaptive Medical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100670082000528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-23
Device Publish Date2022-12-23

Devices Manufactured by Synaptive Medical Inc

00670082000252 - Multi-Tool Calibration Device2025-06-23
00670082000269 - Short Pointer2025-06-23
00670082000351 - Sterilizable Storage Tray2025-06-23
00670082000467 - Modus V2025-06-23 Robotic Digital Microscope
00670082000474 - Modus V2025-06-23 Robotic Digital Microscope
00670082000504 - Modus Nav Software2025-06-23
00670082000528 - Modus Nav Operator Cart2025-06-23
00670082000528 - Modus Nav Operator Cart2025-06-23
00670082000535 - Long Pointer2025-06-23

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