FDA.reportPublic FDA data

Disposable Kit for MIRO Procedure Gmreis

Primary DI
07899258657202
Brand
Disposable Kit for MIRO Procedure Gmreis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
MIRO Kit
Catalog number
338-700
Device description
Disposable Kit for MIRO procedure
Published
2024-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258657202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258657202078992586572027899258657202

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900865213
Device count
1
Premarket exempt
true
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
07899258601670Orthopedic Instruments339-CX-262026-09-24
07901125621176Versalock Mini and Micro Plating System308-15-17-B-BL2026-09-18
07901125621183Versalock Mini and Micro Plating System308-15-19-B-BL2026-09-18
07901125621190Versalock Mini and Micro Plating System308-15-21-B-BL2026-09-18
07901125621206Versalock Mini and Micro Plating System308-15-23-B-BL2026-09-18
07899258654799Stitch - Suture Wires and Tapes333-239-AB1226CI2026-08-27
07899258654805Stitch - Suture Wires and Tapes333-239-PB1226CI2026-08-27
07899258654812Stitch - Suture Wires and Tapes333-20-B2026-08-27
07899258654829Stitch - Suture Wires and Tapes333-20-AB2026-08-27
07899258657141Stitch - Suture Wires and Tapes333-239-B1226CI2026-08-27
07899258665764Stitch - Suture Wires and Tapes333-536-AB1248CO2026-08-27
07899258665771Stitch - Suture Wires and Tapes333-536-B1248CO2026-08-27
07899258665795Stitch - Suture Wires and Tapes333-536-PB1248CO2026-08-27
07899258665863Stitch - Suture Wires and Tapes333-2-018-AB1226CI2026-08-27
07899258665870Stitch - Suture Wires and Tapes333-2-018-B1226CI2026-08-27
07899258665894Stitch - Suture Wires and Tapes333-2-018-PB1226CI2026-08-27
07899258665962Stitch - Suture Wires and Tapes333-13-AB2026-08-27
07899258665986Stitch - Suture Wires and Tapes333-13-B2026-08-27
07899258697864Stitch - Suture Wires and Tapes333-2-018-A1226CI2026-08-27
07899258697871Stitch - Suture Wires and Tapes333-2-090-AB1226CI2026-08-27

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