FDA.reportPublic FDA data

Maestro Couplers, 10mm

Primary DI
03770025849072
Brand
Maestro Couplers, 10mm
Company
Moon Surgical Inc
Model
201
Published
2024-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240598000Maestro System (REF100)Moon Surgical2024-06-03FQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770025849072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770025849072037700258490723770025849072

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 (388) 438-6006support@moonsurgical.com

Regulatory Flags#

DUNS number
117926846
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770025849089Maestro Couplers, 5mm2002024-10-01
03770025849096Maestro System1002024-09-03
27466532979332Maestro Two-Arm Drape3002025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
00724995362317HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362324HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362331HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678757ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678788ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678887ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376729473ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00724995246136HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246143HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246150HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246167HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246174HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246181HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246198HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246204HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246211HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246228HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246235HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246242HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246259HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246266HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246273HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246280HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246297HarmonyAIRSTERIS CORPORATIONFQO2025-11-19