AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 35mm

GUDID 00848665020496

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00848665020496
NIH Device Record Keyed3095ea-cac4-415c-a9ad-6dbfef4e30f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 35mm
Version Model Number8059-035
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
GS100848665020496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665020496]

Moist Heat or Steam Sterilization


[00848665020496]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-03

On-Brand Devices [AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 35mm]

008486650204968059-035
00848665012590S8059-035

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