DFS SMALL FIXATOR

Basic Information

• Brand Name: DFS SMALL FIXATOR
• Primary DI: 00887868081163
• Version / Model: 02026
• Catalog Number: 02026
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f7fb58b9-f39b-44f0-8bf8-8930c005f264

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: 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
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44316	Hand-held telescope	A device that consists of an arrangement of ophthalmic lenses or mirrors with a handle intended to enlarge images for a visually impaired patient/person. It is typically made of plastic, glass and metal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887868081163	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K953406	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0-5 CM