Bioplate@ 81-3596

GUDID M3848135960

5-Tab Zip Implant - 20 mm

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	M3848135960
NIH Device Record Key	6a927b80-408f-4c30-afc3-2abf8fb01d61
Commercial Distribution Discontinuation	2022-02-01
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Bioplate@
Version Model Number	81-3596
Catalog Number	81-3596
Company DUNS	838734093
Company Name	Bioplate, Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter
Length	20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M3848135960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070901

FDA Product Code

GXN	Plate, Cranioplasty, Preformed, Non-Alterable