Model: PRO-1427-16
Catalog: PRO-1427-16
DI: 10888857596931
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
PRO-1427-16
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
21edf05e-9dd8-4e08-85cc-3d5cf610c008
Distribution Status:
In Commercial Distribution
DUNS Number:
119508156
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10888857596931
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43390
Name: Fluted surgical drill bit, single-use
Definition:
A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.
FDA Product Codes
LXH
Orthopedic manual surgical instrument
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
16
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
2.3
Item #2 - Size Type:
Outer Diameter