MIRA

Primary DI
00850038042165
Brand
MIRA
Company
Virtual Incision Corporation
Model
180-090000-000
Catalog number
MIRA-ACC-TCA
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850038042165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038042165008500380421658500380421650850038042165

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041508596
Device count
1
Lot or batch
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
00850038042011MIRA180-010000-000 MIRA-REP-CA12024-06-24
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
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
00850038042011MIRAVirtual 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
00850038042172MIRAVirtual Incision CorporationSAB2024-06-24