AOS TIBIAL NAIL 13mm x 30.0cm

GUDID 00848665016420

ADVANCED ORTHOPEDIC SOLUTIONS INC

Tibia nail, non-sterile
Primary Device ID00848665016420
NIH Device Record Key971c20e9-a29c-4410-9b78-d8bd49ded6a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS TIBIAL NAIL 13mm x 30.0cm
Version Model Number1113-300
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
GS100848665016420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665016420]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-26

On-Brand Devices [AOS TIBIAL NAIL 13mm x 30.0cm]

00848665021837S1113-300
008486650164201113-300

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