Semi-automatic Biopsy-Needle BIM 16/15

GUDID 04262410685093

The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).

ITP Innovative Tomography Products GmbH

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Primary Device ID04262410685093
NIH Device Record Key3a119524-0247-40b2-a773-b7a4d5b6dfe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSemi-automatic Biopsy-Needle BIM 16/15
Version Model NumberBIM 16/15
Company DUNS341493551
Company NameITP Innovative Tomography Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Customer Support Contacts

Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com
Phone+4923454621940
Emailsales@innotom.com

Device Dimensions

Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 Millimeter
Needle Gauge16 Gauge
Length150 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104262410685086 [Primary]
GS104262410685093 [Package]
Contains: 04262410685086
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-29
Device Publish Date2023-11-21

Devices Manufactured by ITP Innovative Tomography Products GmbH

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04262410680074 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
04262410680098 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
04262410680111 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
04262410680210 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
04262410680272 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
04262410680296 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
04262410680333 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
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