Graftgun Universal Graft Delivery System

GUDID 00858406007006

SURGENTEC, LLC

Orthopaedic cement dispenser
Primary Device ID00858406007006
NIH Device Record Key587572a4-5da6-4591-854d-44b15e0634c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGraftgun Universal Graft Delivery System
Version Model NumberGG-U-1000
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
GS100858406007006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-02
Device Publish Date2018-07-02

On-Brand Devices [Graftgun Universal Graft Delivery System]

00858406007006GG-U-1000
00858406007426Graftgun Universal Graft Delivery System labeled with a different catalog for Integrity Implants

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