BioResorb® Macro Pore KE 19005120

GUDID 04260310344041

500-1000 µm; 1 x 2.0 ml

Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien

Synthetic bone graft
Primary Device ID04260310344041
NIH Device Record Key1386cd37-ab2b-469a-8088-3506645756e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioResorb® Macro Pore
Version Model NumberKE 19005120
Catalog NumberKE 19005120
Company DUNS332192830
Company NameBiovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien
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 Datefalse
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
GS104260310344041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone Grafting Material, Synthetic

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 Date2015-09-25

On-Brand Devices [BioResorb® Macro Pore]

042603103441571400-3200 µm; 1 x 2.0 ml
042603103441401400-3200 µm; 1 x 1.0 ml
042603103441331000-2000 µm; 5 x 2.0 ml
042603103441261000-2000 µm; 5 x 1.0 ml
042603103441191000-2000 µm; 5 x 0.5 ml
042603103441021000-2000 µm; 1 x 2.0 ml
042603103440961000-2000 µm; 1 x 1.0 ml
042603103440891000-2000 µm; 1 x 0.5 ml
04260310344072500-1000 µm; 5 x 2.0 ml
04260310344065500-1000 µm; 5 x 1.0 ml
04260310344058500-1000 µm; 5 x 0.5 ml
04260310344041500-1000 µm; 1 x 2.0 ml
04260310344034500-1000 µm; 1 x 1.0 ml
04260310344027500-1000 µm; 1 x 0.5 ml
04260310344010200-500 µm; 5 x 0.5 ml
04260310344003200-500 µm; 1 x 0.5 ml

Trademark Results [BioResorb]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIORESORB
BIORESORB
79018098 3189641 Live/Registered
Kerr GmbH
2004-12-23

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