NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982189363
• Version / Model: 315.40S
• Catalog Number: 31540S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-26
• Public Version: 2
• Public Version Date: 2022-04-29
• Public Version Status: Update
• Public Device Record Key: 78192632-767a-40ee-ade5-4d6e54cbcb06

Device Description

4.0MM THREE-FLUTED DRILL BIT QC/195MM-STERILE

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	General, Plastic Surgery	878.4820	1
HSZ	Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment	General, Plastic Surgery	878.4820	1
GFF	BUR, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4820	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
Secondary	H67931540S0	HIBCC
Primary	10886982189363	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]