FDA.reportPublic FDA data

Maestro System

Primary DI
03770025849096
Brand
Maestro System
Company
Moon Surgical Inc
Model
100
Device description
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Published
2024-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered
QZBSoftware Controlled Endoscope And Instrument Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1
QZBSoftware Controlled Endoscope And Instrument HolderGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240598000
K242323000
K250984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240598000Maestro System (REF100)Moon Surgical2024-06-03FQO
K242323000Maestro System (REF100)Moon Surgical2025-03-14QZB
K250984000Maestro System (REF100)Moon Surgical2025-06-27QZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770025849096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770025849096037700258490963770025849096

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (833) 438-6006support@moonsurgical.com

Regulatory Flags#

DUNS number
117926846
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770025849072Maestro Couplers, 10mm2012024-10-01
03770025849089Maestro Couplers, 5mm2002024-10-01
27466532979332Maestro Two-Arm Drape3002025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995363024STERISSTERIS CORPORATIONFQO2026-10-08
00724995363031STERISSTERIS CORPORATIONFQO2026-10-08
00724995363048STERISSTERIS CORPORATIONFQO2026-10-08
00724995363116STERISSTERIS CORPORATIONFQO2026-10-08
00724995363123STERISSTERIS CORPORATIONFQO2026-10-08
00724995363147STERISSTERIS CORPORATIONFQO2026-10-08
00724995363154STERISSTERIS CORPORATIONFQO2026-10-08
00724995363161STERISSTERIS CORPORATIONFQO2026-10-08
00724995363291NASTERIS CORPORATIONFQO2026-10-08
00724995363307NASTERIS CORPORATIONFQO2026-10-08
00724995363369NASTERIS CORPORATIONFQO2026-10-08
00724995363376NASTERIS CORPORATIONFQO2026-10-08
00724995363383NASTERIS CORPORATIONFQO2026-10-08
00724995363390NASTERIS CORPORATIONFQO2026-10-08
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00724995363901NASTERIS CORPORATIONFQO2026-10-08
00724995363918NASTERIS CORPORATIONFQO2026-10-08
04260463842357Sterile SetAktormed GmbHQZB2026-09-04
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04260463845341BUNDLE JOYSTICK-RH-USAktormed GmbHQZB2026-09-04
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23