FDA.reportPublic FDA data

HandCut

Primary DI
08058341211885
Brand
HandCut
Company
MDL SRL
Model
PM14074
Catalog number
PM14074
Device description
10 CS- DISPOSABLE NEEDLE 14G x 74mm FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION
Published
2017-01-04
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
08058341211885PackageGS110In Commercial Distribution
08058341211892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341211885080583412118858058341211885
08058341211892080583412118928058341211892

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
Needle Gauge14Gauge

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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