Primary Device ID | M263W21000 |
NIH Device Record Key | dc7c8151-2d96-4327-971b-f863f32d94c2 |
Commercial Distribution Discontinuation | 2019-09-30 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | WizardBio Resorbable Calcium Phosphate Cement |
Version Model Number | 21004-10 |
Catalog Number | W21000 |
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 |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M263W21000 [Primary] |
OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-01 |
Device Publish Date | 2019-01-02 |
M263W23000 | WizardBio Resorbable Calcium Phosphate Cement |
M263W21000 | WizardBio Resorbable Calcium Phosphate Cement |
M263W25000 | WizardBio Resorbable Calcium Phosphate Cement |