FDA.report

FastCutM

Primary DI
08058341218907
Brand
FastCutM
Company
MDL SRL
Model
MGC1825
Catalog number
MGC1825
Device description
GUILLOTINE NEEDLE 18G X 250MM FOR SOFT TISSUE BIOPSY FOR MAGNUM BARD TM AND PALIUM GUN,WITH COAXIAL
Published
2017-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MJGDevice, Percutaneous, Biopsy

Product Code Classifications

CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08058341218907PackageGS110In Commercial Distribution
08032986351533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08058341218907080583412189078058341218907
08032986351533080329863515338032986351533

GMDN Terms

TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Device Sizes

TypeValueUnit
Length250Millimeter
Needle Gauge18Gauge

Sterilization Methods

Method

Regulatory Flags

DUNS number
447228586
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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