Variable Angle Locking Screw, 3.5mm x 42mm

GUDID 00848665025989

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00848665025989
NIH Device Record Key09855bad-33b7-40d2-ba21-c8061e7f0d54
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariable Angle Locking Screw, 3.5mm x 42mm
Version Model Number8088-042
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC SOLUTIONS INC
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 Datefalse
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
GS100848665025989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665025989]

Moist Heat or Steam Sterilization


[00848665025989]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-04

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