AOS TIBIAL NAIL 9mm x 28.5cm

GUDID 00848665016017

ADVANCED ORTHOPEDIC SOLUTIONS INC

Tibia nail, non-sterile
Primary Device ID00848665016017
NIH Device Record Keybf778673-063b-456c-bc0d-a3f915b507e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS TIBIAL NAIL 9mm x 28.5cm
Version Model Number1109-285
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
GS100848665016017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665016017]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

On-Brand Devices [AOS TIBIAL NAIL 9mm x 28.5cm]

008486650160171109-285
00848665005073S1109-285

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