Bioplate®

Basic Information

• Brand Name: Bioplate®
• Primary DI: M3848135810
• Version / Model: 81-3581
• Catalog Number: 81-3581
• Company Name: Bioplate, Inc.
• Labeler DUNS: 838734093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-03
• Public Version: 4
• Public Version Date: 2022-02-23
• Public Version Status: Update
• Public Device Record Key: badfe6ab-d0df-40f1-8b00-123870d401ee

Device Description

Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), Self-Drilling Screw - 4 mm (6) [10 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	M3848135811	HIBCC		10	In Commercial Distribution
Primary	M3848135810	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082757	000