EMERGE MEDICAL & Design

Basic Information

• Brand Name: EMERGE MEDICAL & Design
• Primary DI: 00886020016111
• Version / Model: 03.010.060.EM
• Catalog Number: 03.010.060.EM
• Company Name: EMERGE MEDICAL, INC.
• Labeler DUNS: 078642955
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-08
• Public Version: 5
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: 52cfbcec-247d-44e8-bb94-2999f144e5f2
• Distribution End Date: 2018-05-01

Device Description

3.2MM THREE-FLUTED DRILL BIT/ QC/330MM/100MM CALIBRATION

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTW	BIT, DRILL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32390	Fluted surgical drill bit, reusable	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886020016111	GS1