Model: 8290-29-070
Catalog: 829029070
DI: 00889024707085
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c46e7a0b-cebb-4371-a362-fc44db9120c0
Distribution Status:
In Commercial Distribution
DUNS Number:
129278169
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:
00889024707085
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
HTW
BIT, DRILL
Device Sizes
Device Size - Size Text:
2.5MM
Device Size - Size Type:
Device Size Text, specify