Themy TY1810

GUDID 28056138586721

DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm

M.D.L. S.R.L.

End-cut biopsy gun handpiece/needle
Primary Device ID28056138586721
NIH Device Record Key0a91d6f3-01a8-4ce7-8e6a-d3da11afe5ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameThemy
Version Model NumberTY1810
Catalog NumberTY1810
Company DUNS447228586
Company NameM.D.L. S.R.L.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter
Needle Gauge18 Gauge
Length100 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108056138586727 [Primary]
GS128056138586721 [Package]
Contains: 08056138586727
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 Date2021-06-01
Device Publish Date2021-05-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.