WizardBio Resorbable Calcium Phosphate Cement W23000

GUDID M263W23000

WizardBio Resorbable Calcium Phosphate Cement

DSM BIOMEDICAL, INC.

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Primary Device ID	M263W23000
NIH Device Record Key	8d72ec24-4d1e-471e-aa41-926d0eed9c03
Commercial Distribution Discontinuation	2019-09-30
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	WizardBio Resorbable Calcium Phosphate Cement
Version Model Number	21004-03
Catalog Number	W23000
Company DUNS	131107757
Company Name	DSM BIOMEDICAL, 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	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 Dimensions

Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M263W23000 [Primary]

FDA Product Code

OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-10-01
Device Publish Date	2019-01-02

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