Automatic Biopsy Needle - BAM 16/20

GUDID 04262410686076

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 ID04262410686076
NIH Device Record Key92bce458-9453-4774-9a95-c2d29664b60d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomatic Biopsy Needle - BAM 16/20
Version Model NumberBAM 16/20
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

Device Dimensions

Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge
Length200 Millimeter
Needle Gauge16 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104262410686069 [Primary]
GS104262410686076 [Package]
Contains: 04262410686069
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-08-30
Device Publish Date2024-08-22

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 16/202024-08-30The 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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