Semi-automatic Biopsy-Needle BIM 18/10

GUDID 04262410685017

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

ITP Innovative Tomography Products GmbH

End-cut biopsy gun handpiece/needle
Primary Device ID04262410685017
NIH Device Record Key7da38991-ac3e-4403-8c05-a1db9e8e3b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameSemi-automatic Biopsy-Needle BIM 18/10
Version Model NumberBIM 18/10
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 Datefalse
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104262410685000 [Primary]
GS104262410685017 [Package]
Contains: 04262410685000
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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-09
Device Publish Date2023-01-25

Devices Manufactured by ITP Innovative Tomography Products GmbH

04262410685178 - Semi-automatic Biopsy-Needle BIM 14/152024-10-16 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410686076 - Automatic Biopsy Needle - BAM 16/202024-08-30 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410680012 - Coaxial Interventional Needle2024-04-16 This needle is intended for puncture and injection.
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.

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