Black Probe 190664

GUDID 07613327595741

MAKO SURGICAL CORP.

Stereotactic surgery system probe, reusable
Primary Device ID07613327595741
NIH Device Record Key26ccddd9-dd6d-4553-b1ef-0b692e977b04
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlack Probe
Version Model Number190664
Catalog Number190664
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
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 Batchtrue
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
GS107613327595741 [Primary]

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


[07613327595741]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-16
Device Publish Date2026-01-08

Devices Manufactured by MAKO SURGICAL CORP.

07613327522006 - Mako2026-01-22 MICS 3 Handpiece
07613327595505 - Mako Glenoid Retractor2026-01-16
07613327595741 - Black Probe2026-01-16
07613327595741 - Black Probe2026-01-16
07613327523874 - Mako2025-02-14 MICS Sagittal Saw Attachment , Angled
07613327627220 - Mako2024-11-26 MAKO SHOULDER ROUTER
07613327627565 - Mako2024-11-26 MICS SAGITTAL BLADE, STANDARD
07613327627572 - Mako2024-11-26 Blade-Narrow
07613327626971 - Mako2024-11-25 Mako Shoulder Array Kit

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.