Device
Long Drill 2.4mm x 200mm (for 4.0mm Half Pins)
Manufacturer
Paragon 28, Inc.
Model: P45-960-2420 Catalog: P45-960-2420 DI: 00889795152640 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-06 Current Version: 2026-05-14
Description
Long Drill 2.4mm x 200mm (for 4.0mm Half Pins)
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 9a2e56cd-125d-41b1-a6f5-eaa643d200a1
Distribution Status: In Commercial Distribution
DUNS Number: 042961576
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: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00889795152640
Type: Primary
Issuing Agency: GS1
GMDN
Code: 61235
Name: Cannulated surgical drill bit, single-use
Definition:
A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
FDA Product Codes
HTW
BIT, DRILL