FDA.reportPublic FDA data

Symani Accessories Master Holder

Primary DI
18055713175032
Brand
Symani Accessories Master Holder
Company
MEDICAL MICROINSTRUMENTS, INC.
Model
ACC-300
Device description
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
Published
2025-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SAQElectromechanical System For Open Microsurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAQElectromechanical System For Open MicrosurgeryGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055713175032PackageGS16In Commercial Distribution
08055713175035PrimaryGS10
88055713175031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805571317503218055713175032
08055713175035080557131750358055713175035
8805571317503188055713175031

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435958412
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055713170146"Symani Surgical Robot CMM Plug type ""B"""CMM-B0102025-04-21
08055713170504Symani Surgical Robot ConsoleCNS-1002025-04-21
08055713170511Symani Surgical Robot Console FlatCNS-0002025-04-21
08055713171082ScissorsINS-RfM32202026-03-06
08055713171099ForcepsINS-PbM12212026-03-06
08055713177046Synaptix Plug B TypeDWS-B1J000000W2026-03-06
08055713175011Symani Accessories Master ClipACC-2002025-04-21
08055713175028Symani Accessories Contoured Master ClipACC-2202025-04-21
08055713175035Symani Accessories Master HolderACC-3002025-04-21
08055713171020Symani NanoWrist Instruments Micro Needle HolderINS-AaT22212025-04-21
08055713171037Symani NanoWrist Instruments Micro Needle Holder Suture CutINS-AeT12212025-04-21
08055713171044Symani NanoWrist Instruments Micro DilatorINS-ObM12212025-04-21
08055713171051Symani NanoWrist Instruments SuperMicro Needle HolderINS-NaS22212025-04-21
08055713171068Symani NanoWrist Instruments SuperMicro DilatorINS-DbS12212025-04-21
08055713171075Symani NanoWrist Instruments SuperMicro Needle Holder Suture CutINS-NeS12212025-04-21
08055713175004Symani Accessories Instrument ConnectorACC-1012025-04-21
88055713175017Symani Accessories Master ClipACC-2002025-04-21
18055713175025Symani Accessories Contoured Master ClipACC-2202025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055713171082ScissorsMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713171099ForcepsMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713177046Synaptix Plug B TypeMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713175011Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175028Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175035Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170146"Symani Surgical Robot CMM Plug type ""B"""MEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170504Symani Surgical Robot ConsoleMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170511Symani Surgical Robot Console FlatMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171020Symani NanoWrist Instruments Micro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171037Symani NanoWrist Instruments Micro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171044Symani NanoWrist Instruments Micro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171051Symani NanoWrist Instruments SuperMicro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171068Symani NanoWrist Instruments SuperMicro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171075Symani NanoWrist Instruments SuperMicro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175004Symani Accessories Instrument ConnectorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
88055713175017Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
18055713175025Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21