Inion BioRestore™ BRS-5431

GUDID M224BRS54319

Morsels 4.5 cc

Inion Oy

Synthetic bone graft
Primary Device IDM224BRS54319
NIH Device Record Keyc4c781f6-aa2f-4516-870d-4517d8ee8792
Commercial Distribution StatusIn Commercial Distribution
Brand NameInion BioRestore™
Version Model Number1
Catalog NumberBRS-5431
Company DUNS367994657
Company NameInion Oy
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
GS106438408003097 [Secondary]
HIBCCM224BRS54319 [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 Date2019-11-15
Device Publish Date2017-02-07

On-Brand Devices [Inion BioRestore™]

M224BRS54609Oval, small 4 mm
M224BRS54319Morsels 4.5 cc
M224BRS54309Morsels 1.5 cc
M224BRS54139Oval 7 mm
06438408009327Cylinder 8 x 15 mm
06438408009310Block 60 x 40 x 8 mm
06438408009303Block 30 x 20 x 8 mm
06438408009297Block 15 x 25 x 4 mm
06438408009280Block 5 x 10 x 4 mm
06438408009273Block, Wedge 13 mm
06438408009266Block, Wedge 4 mm
06438408009259Block, Gradient 13 mm
06438408009242Block, Gradient 4 mm
06438408009013Oval 13 mm
06438408009006Oval 9 mm
06438408008993Oval 8 mm
06438408008979Oval 6 mm
06438408008962Oval 5 mm
06438408008955Oval 4 mm
06438408009334Oval, small 4 mm
06438408008986Oval 7 mm
06438408003097Morsels 4.5 cc
06438408003080Morsels 1.5 cc

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