MIRA

Primary DI
00850038042011
Brand
MIRA
Company
Virtual Incision Corporation
Model
180-010000-000
Catalog number
MIRA-REP-CA1
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
SABTable Mounted Miniaturized Electromechanical Surgical System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SABTable Mounted Miniaturized Electromechanical Surgical SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230025000MIRA Surgical SystemVirtual Incision2024-02-23SAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038042011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038042011008500380420118500380420110850038042011

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cine cameraAn electro-optical device that is designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to obtain moving-picture documentation of endoscopic findings and procedures. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It records a sequence of photographs and usually projects them sequentially to obtain a motion picture. The device may also include audio recording capabilities.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
041508596
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038042004MIRA180-000000-000MIRA-REP-MB12024-06-24
00850038042028MIRA180-020000-0002024-06-24
00850038042042MIRA180-040000-0002024-06-24
00850038042059MIRA180-050000-101MIRA-SUD-BPG2024-06-24
00850038042066MIRA180-050000-102MIRA-SUD-MPS2024-06-24
00850038042097MIRA180-130000-100MIRA-SUD-NLP2024-06-24
00850038042158MIRA180-080000-000MIRA-ACC-TMB2024-06-24
00850038042165MIRA180-090000-000MIRA-ACC-TCA2024-06-24
00850038042172MIRA180-070000-000MIRA-ACC-SAA2024-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850038042004MIRAVirtual Incision CorporationSAB2024-06-24
00850038042028MIRAVirtual Incision CorporationSAB2024-06-24
00850038042042MIRAVirtual Incision CorporationSAB2024-06-24
00850038042059MIRAVirtual Incision CorporationSAB2024-06-24
00850038042066MIRAVirtual Incision CorporationSAB2024-06-24
00850038042097MIRAVirtual Incision CorporationSAB2024-06-24
00850038042158MIRAVirtual Incision CorporationSAB2024-06-24
00850038042165MIRAVirtual Incision CorporationSAB2024-06-24
00850038042172MIRAVirtual Incision CorporationSAB2024-06-24