Porous Wedge - Cotton 5 mm NB5705

GUDID 00813909013428

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID00813909013428
NIH Device Record Keyc0bbece1-818f-443c-b8d5-2b2f0827f5ce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePorous Wedge - Cotton 5 mm
Version Model NumberNB5705
Catalog NumberNB5705
Company DUNS828813290
Company NameNOVABONE PRODUCTS, LLC
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100813909013428 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-17
Device Publish Date2025-04-09

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