PROFYLE

Basic Information

• Brand Name: PROFYLE
• Primary DI: 07613154583829
• Version / Model: 59-12049E
• Catalog Number: 59-12049E
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-24
• Public Version: 8
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: eca9b016-8024-4aa5-9a4d-d4c068cd4c7d

Device Description

WASHER FOR 1.2MM BONE SCREWS

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613154583829	GS1

Premarket Submissions

Submission Number	Supplement Number
K062498	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter: 2.2 Millimeter
Device Size Text, specify			Thickness: 0.55 Millimeter