Bioplate® 81-3590

GUDID M3848135901

Straight Plate - Low-Profile - 2 hole - 11 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]

Bioplate, Inc.

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: M3848135901
• NIH Device Record Key: 1bc91139-94fb-459f-afe4-5fa4d918403e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioplate®
• Version Model Number: 81-3590
• Catalog Number: 81-3590
• Company DUNS: 838734093
• Company Name: Bioplate, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com
• Phone: 888-246-7528
• Email: INFO@bioplate.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M3848135900 [Primary]
HIBCC	M3848135901 [Package]; Contains: M3848135900; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082757

FDA Product Code

• JEY: Plate, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-02-23
• Device Publish Date: 2015-12-03

On-Brand Devices [Bioplate®]

• M384SCR812051: Screw - Ø1.5 mm x 12 mm (5 PK)
• M384SCR812010: Screw - Ø1.2 mm x 12 mm
• M384SCR810051: Screw - Ø1.2 mm x 10 mm [5 PK]
• M384SCR810010: Screw - Ø1.2 mm x 10 mm
• M384SCR80805US1: Screw - Ø1.2 mm x 8 mm [5 PK]
• M384SCR808051: Screw - Ø1.2 mm x 8 mm [5 PK]
• M384SCR808010: Screw - Ø1.2 mm x 8 mm
• M384SCR80605US1: Screw - Ø1.2 mm x 6 mm [5 PK]
• M384SCR806051: Screw - Ø1.2 mm x 6 mm [5 PK]
• M384SCR806010: Screw - Ø1.2 mm x 6 mm
• M384SCR80505US1: Screw - Ø1.2 mm x 5 mm [5 PK]
• M384SCR805051: Screw - Ø1.2 mm x 5 mm [5 PK]
• M384SCR805010: Screw - Ø1.2 mm x 5 mm
• M384SCR80405US1: Screw - Ø1.2 mm x 4 mm [5 PK]
• M384SCR804051: Screw - Ø1.2 mm x 4 mm [5 PK]
• M384SCR804010: Screw - Ø1.2 mm x 4 mm
• M384SCR80305US1: Screw - Ø1.2 mm x 3 mm [5 PK]
• M384SCR803051: Screw - Ø1.2 mm x 3 mm [5 PK]
• M384SCR803010: Screw - Ø1.2 mm x 3 mm
• M384SCR41705US1: Screw - Ø2.0 mm x 17 mm [5 PK]
• M384SCR417051: Screw - Ø2.0 mm x 17 mm [5 PK]
• M384SCR417010: Screw - Ø2.0 mm x 17 mm
• M384SCR41505US1: Screw - Ø2.0 mm x 15 mm [5 PK]
• M384SCR415051: Screw - Ø2.0 mm x 15 mm [5 PK]
• M384SCR415010: Screw - Ø2.0 mm x 15 mm
• M384SCR414051: Screw - Ø2.0 mm x 14 mm [5 PK]
• M384SCR414010: Screw - Ø2.0 mm x 14 mm
• M384SCR41305US1: Screw - Ø2.0 mm x 13 mm [5 PK]
• M384SCR413051: Screw - Ø2.0 mm x 13 mm [5 PK]
• M384SCR413010: Screw - Ø2.0 mm x 13 mm
• M384SCR412051: Screw - Ø2.0 mm x 12 mm [5 PK]
• M384SCR41201: Screw - Ø2.0 mm x 12 mm
• M384SCR41105US1: Screw - Ø2.0 mm x 11 mm [5 PK]
• M384SCR411051: Screw - Ø2.0 mm x 11 mm [5 PK]
• M384SCR411010: Screw - Ø2.0 mm x 11 mm
• M384SCR410051: Screw - Ø2.0 mm x 10 mm [5 PK]
• M384SCR410010: Screw - Ø2.0 mm x 10 mm
• M384SCR40905US1: Screw - Ø2.0 mm x 9 mm [5 PK]
• M384SCR409051: Screw - Ø2.0 mm x 9 mm [5 PK]
• M384SCR409010: Screw - Ø2.0 mm x 9 mm
• M384SCR408051: Screw - Ø2.0 mm x 8 mm [5 PK]
• M384SCR408010: Screw - Ø2.0 mm x 8 mm
• M384SCR40705US1: Screw - Ø2.0 mm x 7 mm [5 PK]
• M384SCR407051: Screw - Ø2.0 mm x 7 mm [5 PK]
• M384SCR407010: Screw - Ø2.0 mm x 7 mm
• M384SCR40605US1: Screw - Ø2.0 mm x 6 mm [5 PK]
• M384SCR406051: Screw - Ø2.0 mm x 6 mm [5 PK]
• M384SCR406010: Screw - Ø2.0 mm x 6 mm
• M384SCR40505US1: Screw - Ø2.0 mm x 5 mm [5 PK]
• M384SCR405051: Screw - Ø2.0 mm x 5 mm [5 PK]