Automatic Biopsy Needle - BAM 16/20

Basic Information

• Brand Name: Automatic Biopsy Needle - BAM 16/20
• Primary DI: 04262410686069
• Version / Model: BAM 16/20
• Company Name: ITP Innovative Tomography Products GmbH
• Labeler DUNS: 341493551
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-22
• Public Version: 1
• Public Version Date: 2024-08-30
• Public Version Status: New
• Public Device Record Key: 92bce458-9453-4774-9a95-c2d29664b60d

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
22726	End-cut biopsy gun handpiece/needle	A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04262410686076	GS1	Box	10	In Commercial Distribution
Primary	04262410686069	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233294	000

Device Sizes

Type	Value	Unit	Text
Length	200	Millimeter
Needle Gauge	16	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 23 Degrees Celsius