FDA.reportPublic FDA data

FastCutS

Primary DI
08058341210604
Brand
FastCutS
Company
MDL SRL
Model
VES1825
Catalog number
VES1825
Device description
DISPOSABLE NEEDLE 18GX250 MM FOR SOFT TISSUE BIOPSY, COMPATIBLE AUTOMATIC STERYLAB FASTGUN ® GUN
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJGDevice, Percutaneous, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058341210604PackageGS110In Commercial Distribution
08032986358013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341210604080583412106048058341210604
08032986358013080329863580138032986358013

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length250Millimeter
Needle Gauge18Gauge

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18056138586243MarkPN2015PN20152021-05-17
18056138586250AutoMarkPNA2005PNA20052021-05-17
18056138586267AutoMarkPNA2010PNA20102021-05-17
18056138586274AutoMarkPNA2015PNA20152021-05-17
18056138586304MarkSlimPNS2010PNS20102021-05-17
18056138586311MarkslimPNS2015PNS20152021-05-17
18056138586366RepoMarkPR2007PR20072021-05-17
18056138586373RepoMarkPR2010PR20102021-05-17
18056138586380RepoMarkPR2015PR20152021-05-17
18056138586397PressToPS0810PS08102021-05-17
18056138586403PressToPS1110PS11102021-05-17
18056138586410PressToPS1115PS11152021-05-17
18056138586427PressToPS1306PS13062021-05-17
18056138586434PressToPS1310PS13102021-05-17
28056138586615ThemyTY1206TY12062021-05-17
28056138586622ThemyTY1209TY12092021-05-17
28056138586639ThemyTY1211TY12112021-05-17
28056138586646ThemyTY1410TY14102021-05-17
28056138586653ThemyTY1412TY14122021-05-17
28056138586660ThemyTY1416TY14162021-05-17

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