Device
Drill, 2.0mm
Manufacturer
Pace Surgical, Inc.
Model: PS2-2000020 Catalog: PS2-2000020 DI: 00810211043860 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-27 Current Version: 2026-05-05
Description
Drill, 2.0mm
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: 02afb869-df1f-4d45-85e9-69b612356a06
Distribution Status: In Commercial Distribution
DUNS Number: 119302878
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: 00810211043860
Type: Primary
Issuing Agency: GS1
GMDN
Code: 32390
Name: Fluted surgical drill bit, reusable
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 usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.
FDA Product Codes
HTW
Bit, Drill