"1.5MM" SYSTEM PLATE

Basic Information

• Brand Name: "1.5MM" SYSTEM PLATE
• Primary DI: 00841036013370
• Version / Model: 01-7182
• Catalog Number: 01-7182
• Company Name: BIOMET MICROFIXATION, INC
• Labeler DUNS: 046189866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 95228599-f9ec-45de-b3cc-2186c7d630d4

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
GXR	COVER, BURR HOLE	Neurology	882.5250	2
GWO	Plate, cranioplasty, preformed, alterable	Neurology	882.5320	2
HBW	FASTENER, PLATE, CRANIOPLASTY	Neurology	882.5360	2
JEY	PLATE, BONE	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35651	Cranioplasty sheet	A flat piece of implantable metal (typically tantalum) designed to repair small cranial bone defects (i.e., cranioplasty). It is usually perforated and can be shaped to a desired contour using a mallet and a wood block and cut with shears to an appropriate dimension, intraoperatively. Prefabricated metallic plates, which may be manufactured from metallic sheets, are frequently used to repair larger cranial bone defects.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841036013370	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121589	000
K121624	000
K953385	000