Device
A needle biopsy system consisting of a needle and an instrument ("gun") to facilitate biopsy of soft tissue. The needle is advanced to the target tissue under image guidance and th...
Manufacturer
URO-1, INC.
URO-1, INC.
Model: SP-LA18-22
Catalog: SP-LA18-22
DI: 00860014338625
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Distribution End: 2029-12-31
Description
A needle biopsy system consisting of a needle and an instrument ("gun") to facilitate biopsy of soft tissue. The needle is advanced to the target tissue under image guidance and then the instrument fires the needle in order to obtain a core of tissue that then is prepared for analysis by a pathologist.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ff34acca-c45d-4746-abce-fb9e96be1b1f
Distribution Status:
In Commercial Distribution
DUNS Number:
082407801
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Tray with Tyvek lid
Item #1 - Device ID:
00860014338618
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00860014338625
Item #1 - Pkg Discontinue Date:
2029-12-31
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00860014338625
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 64326
Name: Biopsy gun handpiece, mechanical
Definition:
A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. 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 reusable device.
FDA Product Codes
KNW
Instrument, Biopsy