SPE-Instrument PERLA ®

Basic Information

• Brand Name: SPE-Instrument PERLA ®
• Primary DI: 07640185348325
• Version / Model: SPE-US FD 18-N
• Catalog Number: SPE-US FD 18-N
• Company Name: SpineArt SA
• Labeler DUNS: 483016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-29
• Public Version: 1
• Public Version Date: 2021-04-06
• Public Version Status: New
• Public Device Record Key: a74f31fb-0e5e-4c07-976a-6e425c071b28

Device Description

FIXED DRILL L18

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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	07640185348325	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.4	Millimeter
Length	18	Millimeter