OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSAL

GUDID 00810131881146

SURGENTEC, LLC

Orthopaedic cement, non-antimicrobial
Primary Device ID00810131881146
NIH Device Record Key636f8c48-d8bf-497a-a1a7-3c07f249fa7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSAL
Version Model NumberONP-S-10 - IB
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
GS100810131881146 [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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00810131880491 - TiLink-L Implant 60mm x 10mm2025-06-18
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