Model: C
Catalog: KBD1115
DI: 00884450681312
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
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7200d212-a812-4ea7-9d82-519f68159ff4
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10884450681319
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
14
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450681312
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450681312
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60477
Name: Bone biopsy needle
Definition:
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.
FDA Product Codes
GAA
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE