Semi-automatic Biopsy Needle - BIM18/10i

GUDID 04262410680845

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 ID: 04262410680845
• NIH Device Record Key: e1654b1b-f38f-4666-8107-b6a017113c6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Semi-automatic Biopsy Needle - BIM18/10i
• Version Model Number: BIM18/10i
• Company DUNS: 341493551
• Company Name: ITP Innovative Tomography Products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com
• Phone: +4923454621940
• Email: sales@innotom.com

Device Dimensions

• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04262410680845 [Package]; Contains: 04262410680852; Package: Box [10 Units]; In Commercial Distribution
GS1	04262410680852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233294

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-22
• Device Publish Date: 2025-09-12

Devices Manufactured by ITP Innovative Tomography Products GmbH

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• 04262410680845 - Semi-automatic Biopsy Needle - BIM18/10i: 2025-09-22The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
• 04262410680845 - Semi-automatic Biopsy Needle - BIM18/10i: 2025-09-22 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
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• 04262410687066 - Semi-automatic Biopsy Needle - BIM18/15i: 2025-07-17 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
• 04262410687028 - Semi-automatic Biopsy Needle - BIM18/20i: 2025-05-07 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
• 04262410686090 - Automatic Biopsy Needle - BAM 16/17: 2025-05-01 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
• 04262410686113 - Automatic Biopsy Needle - BAM 16/15: 2025-05-01 The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).