Home GUDID 07350086550221
OSSDSIGN Cranioplug
Primary DI 07350086550221
Brand OSSDSIGN Cranioplug
Company Ossdsign AB
Model 14 mm, 2 fixation-points
Catalog number n/a
Device description OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanicalperformance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Published 2019-06-05
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GXR Cover, Burr Hole
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXR Cover, Burr Hole Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17350086550228 Package GS1 10 In Commercial Distribution 27350086550225 Package GS1 1 In Commercial Distribution 07350086550221 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17350086550228 17350086550228 27350086550225 27350086550225 07350086550221 07350086550221 7350086550221
GMDN Terms# Term, Definition table Term Definition Cranial bur hole cover A sterile device used to cover or to plug holes drilled into the skull during surgery and to reattach cranial bone removed during the intervention. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Outer Diameter 14 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 34 Degrees Celsius Storage Environment Temperature 40 Degrees Fahrenheit 93 Degrees Fahrenheit
Regulatory Flags# DUNS number 350354370 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08806390889049 Leforte Neuro System Bone Plate Jeil Medical Corporation GXR 2023-11-30 G28436102 NuCrani Large Plate Neurovention LLC GXR 2022-06-21 08806390888851 Leforte Neuro System Bone Plate Jeil Medical Corporation GXR 2022-05-03 07613327543032 DELTA Stryker Leibinger GmbH & Co. KG GXR 2020-12-15 08809416061542 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061559 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061566 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061573 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061580 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061603 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061627 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061634 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061641 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061658 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061665 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061672 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809416061733 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-14 08809399740946 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809399740953 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809399745231 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809399745248 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809399745255 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809399745279 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809399745286 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809416061535 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809416061689 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809416061696 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809416061702 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809416061719 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13 08809416061726 Neuro Plating System OSTEONIC CO.,Ltd. GXR 2019-02-13