NA

Basic Information

• Brand Name: NA
• Primary DI: 10887587038520
• Version / Model: 317.432
• Catalog Number: 317432
• Company Name: SYNTHES (U.S.A.) LP
• Labeler DUNS: 832637081
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 5
• Public Version Date: 2020-06-29
• Public Version Status: Update
• Public Device Record Key: df7b3009-a78a-4924-8704-4388e1c7f942
• Distribution End Date: 2020-06-28

Device Description

1.5MM DRILL BIT/UNIVERSAL-HALL 85MM

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: 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
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	General, Plastic Surgery	878.4820	1
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1
GFF	BUR, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4820	1
HSZ	Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment	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	H9803174320	HIBCC
Primary	10887587038520	GS1

Customer Contacts

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