OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10cc

GUDID 00858406007693

SURGENTEC, LLC

Orthopaedic cement, non-antimicrobial
Primary Device ID00858406007693
NIH Device Record Key62126b66-d35c-4349-b890-dd47d1c40660
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10cc
Version Model NumberONP-U-10
Company DUNS004095409
Company NameSURGENTEC, 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 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
GS100858406007693 [Primary]

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 Date2025-06-18
Device Publish Date2025-06-10

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