Semi-automatic Biopsy-Needle BIM 14/10

GUDID 04262410685130

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 ID04262410685130
NIH Device Record Keyd06ac6cb-87ab-4266-86c5-82d66352c639
Commercial Distribution StatusIn Commercial Distribution
Brand NameSemi-automatic Biopsy-Needle BIM 14/10
Version Model NumberBIM 14/10
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

Device Dimensions

Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 Gauge
Length100 Millimeter
Needle Gauge14 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104262410685123 [Primary]
GS104262410685130 [Package]
Contains: 04262410685123
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 Date2024-02-16
Device Publish Date2024-02-08

Devices Manufactured by ITP Innovative Tomography Products GmbH

04262410686038 - Automatic Biopsy Needle - BAM 18/172024-12-16 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410686014 - Automatic Biopsy Needle - BAM 18/202024-11-26 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
04262410686052 - Automatic Biopsy Needle - BAM 18/152024-11-26 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
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.

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