FDA.report

Disposable Kit for MIRO Procedure Gmreis

Primary DI
07899258657059
Brand
Disposable Kit for MIRO Procedure Gmreis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
MIRO Guide Wire
Catalog number
338-118S
Device description
GUIDE WIRE Ø2.0x150mm
Published
2024-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899258657059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899258657059078992586570597899258657059

GMDN Terms

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

Regulatory Flags

DUNS number
900865213
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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