Bioplate@ 81-3518

GUDID M3848135181

Zip® Implant - 20 mm (STERILE) [6 PK]

Bioplate, Inc

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable

• Primary Device ID: M3848135181
• NIH Device Record Key: b4ae00cd-0370-4f32-bde1-c04f6226bce1
• Commercial Distribution Discontinuation: 2022-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bioplate@
• Version Model Number: 81-3518
• Catalog Number: 81-3518
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M3848135180 [Primary]
HIBCC	M3848135181 [Package]; Contains: M3848135180; Package: [6 Units]; Discontinued: 2022-02-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070901

FDA Product Code

• GXN: Plate, Cranioplasty, Preformed, Non-Alterable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-02-02
• Device Publish Date: 2015-12-03

On-Brand Devices [Bioplate@]

• M384P3ST16860: Straight Plate - Ø1.9 mm - 16 hole - 86 mm
• M384P3SB04200: Straight Plate - Ø1.9 mm - 4 hole - 20 mm
• M384P3SB0212051: Straight Plate - Ø1.9 mm - 2 hole - 12 mm [5 PK]
• M384P2SB04210: Xpress ® Straight Plate - Ø1.5 mm - 4 hole - 21 mm
• M3848135960: 5-Tab Zip Implant - 20 mm
• M384813595US0: 5-Tab Zip Implant - 16 mm
• M3848135950: 5-Tab Zip Implant - 16 mm
• M3848135940: 5-Tab Zip Implant - 12 mm
• M3848135181: Zip® Implant - 20 mm (STERILE) [6 PK]
• M3848135171: Zip® Implant - 16 mm (STERILE) [6 PK]
• M3848135161: Zip® Implant - 12 mm (STERILE) [6 PK]