CERAMENT™BONE VOID FILLER A0210-08

GUDID 07350055430035

Bone Support AB

Bone matrix implant, synthetic
Primary Device ID07350055430035
NIH Device Record Keya98f4ab6-db42-4a11-97fd-226e61cf8674
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERAMENT™BONE VOID FILLER
Version Model NumberA0210-08
Catalog NumberA0210-08
Company DUNS350066052
Company NameBone Support AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350055430035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-06
Device Publish Date2015-09-17

On-Brand Devices [CERAMENT™BONE VOID FILLER ]

07350055430066A0210-11
07350055430042A0210-09
07350055430035A0210-08

Trademark Results [CERAMENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CERAMENT
CERAMENT
87150885 5604069 Live/Registered
BoneSupport AB
2016-08-25
CERAMENT
CERAMENT
79020794 3298199 Live/Registered
Bone Support AB
2005-11-10
CERAMENT
CERAMENT
77192160 3571152 Live/Registered
Bone Support AB
2007-05-29

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