Bioplate®

Basic Information

• Brand Name: Bioplate®
• Primary DI: M384813591US0
• Version / Model: 81-3591[US]
• Catalog Number: 81-3591[US]
• Company Name: Bioplate, Inc.
• Labeler DUNS: 838734093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-27
• Public Version: 4
• Public Version Date: 2022-02-23
• Public Version Status: Update
• Public Device Record Key: f9d18661-68ee-426b-99f8-487863bc82e4

Device Description

Straight Plate - Low-Profile - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JEY	Plate, Bone	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M384813591US1	HIBCC		5	In Commercial Distribution
Primary	M384813591US0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082757	000