MIRA

Primary DI
00850038042172
Brand
MIRA
Company
Virtual Incision Corporation
Model
180-070000-000
Catalog number
MIRA-ACC-SAA
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850038042172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038042172008500380421728500380421720850038042172

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041508596
Device count
1
Lot or batch
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
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
00850038042165MIRA180-090000-000MIRA-ACC-TCA2024-06-24

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
00850038042165MIRAVirtual Incision CorporationSAB2024-06-24