AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 38cm

GUDID 00848665017793

ADVANCED ORTHOPEDIC SOLUTIONS INC

Femur nail, non-sterile
Primary Device ID00848665017793
NIH Device Record Key52c6df8e-1cf8-47cc-9d55-69fe5817fd3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 38cm
Version Model Number1314-038
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
GS100848665017793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665017793]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-27

On-Brand Devices [AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 38cm]

008486650177931314-038
00848665011913S1314-038

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