Synthacer/Syntricer 6.1/7.1CB1.5

GUDID 04250971422097

Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 3 ml

medArtis Medizinprodukte und Forschung Aktiengesellschaft

Bone matrix implant, synthetic
Primary Device ID04250971422097
NIH Device Record Key57423e4b-e1fc-480b-8693-a7fe923ab21b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthacer/Syntricer
Version Model NumberT671CB15-3-1
Catalog Number6.1/7.1CB1.5
Company DUNS313163545
Company NamemedArtis Medizinprodukte und Forschung Aktiengesellschaft
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume3 Milliliter
Pore Size300 Micrometer
Outer Diameter1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104250971422097 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [Synthacer/Syntricer]

04250971422097Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 3 ml
04250971422080Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 2 ml
04250971422073Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 1 ml
04250971422066Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 5 ml
04250971422059Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 2 ml
04250971422042Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 1 ml
04250971422035Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
04250971422028Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
04250971422011Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
04250971422004Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
04250971421991Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 6 mm, 10 ml
04250971421984Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 6 mm, 5 ml
04250971421977Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 4 mm, 10 ml
04250971421960Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 30 ml
04250971421953Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 20 ml
04250971421946Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 15 ml
04250971421939Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 10 ml
04250971421922Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 5 ml
04250971421915Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 2 ml
04250971421908Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 1 ml
04250971421892Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 30 ml
04250971421885Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 20 ml
04250971421878Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 15 ml
04250971421861Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 10 ml
04250971421854Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 5 ml
04250971421847Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 2 ml
04250971421830Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 1 ml
04250971421823Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 30 ml
04250971421816Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 20 ml
04250971421809Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 15 ml
04250971421793Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 10 ml
04250971421786Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 5 ml
04250971421779Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 2 ml
04250971421762Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 1 ml
04250971401412Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 0.5 ml
04250971400705Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 4 mm, 5 ml

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