AccessGUDID - DEVICE: Automatic Biopsy Needle

GUDID

Device Identifier (DI) Information

Brand Name: Automatic Biopsy Needle - BAM 16/15
Version or Model: BAM16/15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ITP Innovative Tomography Products GmbH

Primary DI Number: 04262410686106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341493551 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233294	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 150 Millimeter
Needle Gauge: 16 Gauge

Device Record Status

Public Device Record Key: 79f2ec2f-ec08-4a0f-bdfb-146de3c14c5d
Public Version Date: May 01, 2025
Public Version Number: 1
DI Record Publish Date: April 23, 2025