Model: 187BL3590
DI: 00763000945794
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
BLADE 187BL3590 AX 3.5MM 90DG
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3e9b86c0-ec9b-40d3-9d16-998b7f98457b
Distribution Status:
In Commercial Distribution
DUNS Number:
835465063
Device Count:
1
DM Exempt:
Yes
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00763000945794
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34848
Name: Metal/carbide ENT bur, single-use
Definition:
A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.
FDA Product Codes
EQJ
BUR, EAR, NOSE AND THROAT
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
11.0
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
3.5
Item #2 - Size Type:
Outer Diameter
Item #3 - Size - @attributes - Unit:
degree
Item #3 - Size - @attributes - Value:
90.0
Item #3 - Size Type:
Angle