Themy TY1610

GUDID 28052440101652

5 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm

M.D.L. SRL

End-cut biopsy gun handpiece/needle
Primary Device ID28052440101652
NIH Device Record Key50a670fa-fabf-4233-9e4f-33e1eac3507b
Commercial Distribution StatusIn Commercial Distribution
Brand NameThemy
Version Model NumberTY1610
Catalog NumberTY1610
Company DUNS447228586
Company NameM.D.L. SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge
Length100 Millimeter
Needle Gauge16 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108052440101658 [Primary]
GS128052440101652 [Package]
Contains: 08052440101658
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25

Devices Manufactured by M.D.L. SRL

28052440101652 - Themy2020-12-035 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
28052440101652 - Themy2020-12-03 5 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
08052440103522 - Intro2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 13G x 44mm
08058341212561 - Intro2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 13G X 50mm
08058341216354 - Intro2019-10-07 COAXIAL INTRODUCER NEEDLE 13G X 75mm
08052440108978 - Intro2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 15G X 95mm
08052440108985 - Intro2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 15GX110mm
08052440108992 - Intro2019-10-07 COAXIAL INTRODUCER NEEDLE 15G X 140mm
08058341216682 - Intro2019-10-07 COAXIAL INTRODUCER NEEDLE 17G X 50mm

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