osteoSPAN 100-SLF

GUDID 00812593020606

6x6x40mm osteoSPAN Blocks

BIOGENNIX LLC

Synthetic bone graft

Primary Device ID	00812593020606
NIH Device Record Key	b6db1f7f-095e-4269-9066-ff5c8fb63584
Commercial Distribution Status	In Commercial Distribution
Brand Name	osteoSPAN
Version Model Number	100-SLF
Catalog Number	100-SLF
Company DUNS	021486533
Company Name	BIOGENNIX LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	6 Millimeter
Width	6 Millimeter
Width	6 Millimeter
Width	6 Millimeter
Width	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter
Length	40 Millimeter
Height	6 Millimeter
Width	6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593020606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093342

FDA Product Code

MQV	Filler, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-12-19

On-Brand Devices [osteoSPAN]

00812593020620	1-4mm osteoSPAN Granules
00812593020613	9x6x40mm osteoSPAN Blocks
00812593020606	6x6x40mm osteoSPAN Blocks

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