MIRA

Primary DI
00850038042097
Brand
MIRA
Company
Virtual Incision Corporation
Model
180-130000-100
Catalog number
MIRA-SUD-NLP
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
00850038042097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038042097008500380420978500380420970850038042097

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, single-useA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041508596
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
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
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
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
00850038042158MIRAVirtual Incision CorporationSAB2024-06-24
00850038042165MIRAVirtual Incision CorporationSAB2024-06-24
00850038042172MIRAVirtual Incision CorporationSAB2024-06-24