MIRA

Primary DI
00850038042059
Brand
MIRA
Company
Virtual Incision Corporation
Model
180-050000-101
Catalog number
MIRA-SUD-BPG
Published
2024-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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
00850038042059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038042059008500380420598500380420590850038042059

GMDN Terms#

Term, Definition table
TermDefinition
Robotic endoscopic electrosurgical instrument, bipolar, single-useA electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and may include the distal bipolar electrode in one of a variety of forms (e.g., forceps, hook). This is a single-use device.

Regulatory Flags#

DUNS number
041508596
Device count
1
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
true
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
00850038042066MIRA180-050000-102MIRA-SUD-MPS2024-06-24
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
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
00850038042011MIRAVirtual Incision CorporationSAB2024-06-24
00850038042028MIRAVirtual Incision CorporationSAB2024-06-24
00850038042042MIRAVirtual 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