BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc ABS-3101

GUDID 00812337020435

Fast-Setting Drillable Calcium Phosphate Cement

DSM BIOMEDICAL, INC.

Composite bone graft
Primary Device ID00812337020435
NIH Device Record Keyde8ad084-89d2-4714-ab07-a2fe84255612
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc
Version Model Number21003-04
Catalog NumberABS-3101
Company DUNS131107757
Company NameDSM BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812337020435 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-17
Device Publish Date2023-05-09

Devices Manufactured by DSM BIOMEDICAL, INC.

00812337020541 - Resolve Matrix™ Biologic Membrane2023-12-26 Resolve Matrix™ 2 cm x 2 cm
00812337020558 - Resolve Matrix™ Biologic Membrane2023-12-26 Resolve Matrix™ 2 cm x 4 cm
00812337020565 - Resolve Matrix™ Biologic Membrane2023-12-26 Resolve Matrix™ 4 cm x 5 cm
00812337020572 - Resolve Matrix™ Biologic Membrane2023-12-26 Resolve Matrix™ 6 cm x 8 cm
00812337020589 - Resolve Matrix™ Biologic Membrane2023-12-26 Resolve Matrix™ 2 cm x 3 cm
00812337020596 - Resolve Matrix™ Biologic Membrane2023-12-26 Resolve Matrix™ 3 cm x 4 cm
00812337020602 - xenoPATCH™2023-12-20
M263W25000 - WizardBio Resorbable Calcium Phosphate Cement2023-06-20 WizardBio Resorbable Calcium Phosphate Cement

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.