OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5cc

GUDID 00858406007648

SURGENTEC, LLC

Orthopaedic cement, non-antimicrobial
Primary Device ID00858406007648
NIH Device Record Key8b237849-4c8f-44f7-9424-189a935a1506
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5cc
Version Model NumberONP-K-500
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
GS100858406007648 [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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