NO-PROFILE

Basic Information

• Brand Name: NO-PROFILE
• Primary DI: 00880304406155
• Version / Model: 904648
• Catalog Number: 904648
• Company Name: Biomet Sports Medicine, LLC
• Labeler DUNS: 627100159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2019-01-08
• Public Version Status: Update
• Public Device Record Key: 1098d778-2b25-4888-aba7-03b0a66bf9b3

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, fixation, bone	Orthopedic	888.3040	2
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36174	Ligament bone anchor	A non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304406155	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981967	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.5 MM 48 MM