VERUM System Bone Screw

GUDID 08806390858069

Jeil Medical Corporation

Orthopaedic bone screw (non-sliding)
Primary Device ID08806390858069
NIH Device Record Key1699a8e5-b6a1-4468-9d9f-ba4b39c532f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERUM System Bone Screw
Version Model NumberPH1509-L
Company DUNS688811603
Company NameJeil Medical Corporation
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806390858069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


[08806390858069]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2024-06-05
Device Publish Date2017-10-25

On-Brand Devices [VERUM System Bone Screw]

08806390859554PR2530
08806390859547PR2528
08806390859530PR2526
08806390859523PR2524
08806390859516PR2522
08806390859509PR2520
08806390859493PR2518
08806390859486PR2516
08806390859479PR2514
08806390859462PR2512
08806390859455PR2510
08806390859448PR2508
08806390859431PR2530-L
08806390859424PR2528-L
08806390859417PR2526-L
08806390859400PR2524-L
08806390859394PR2522-L
08806390859387PR2520-L
08806390859370PR2518-L
08806390859363PR2516-L
08806390859356PR2514-L
08806390859349PR2512-L
08806390859332PR2510-L
08806390859325PR2508-L
08806390858038PH1506-L
08806390858021CC0240
08806390858014CC0230
08806390855341PF2808-L
08806390858199PH1508-H1
08806390858182PH1507-H1
08806390858175PH1506-H1
08806390858144PH1520-L
08806390858137PH1518-L
08806390858120PH1516-L
08806390858113PH1514-L
08806390858106PH1513-L
08806390858090PH1512-L
08806390858083PH1511-L
08806390858076PH1510-L
08806390858069PH1509-L
08806390858052PH1508-L
08806390858045PH1507-L
08806390857895CC6080-L
08806390857888CC6075-L
08806390857871CC6070-L
08806390857864CC6065-L
08806390857857CC6060-L
08806390857840CC6055-L
08806390857833CC6050-L
08806390857826CC6045-L

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.