ES™ RETROGRADE FEMORAL NAIL 13mm x 34cm

GUDID 00848665034745

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile
Primary Device ID00848665034745
NIH Device Record Key49a8b7f5-b3a5-46cf-b08b-6c6acefe6ac5
Commercial Distribution StatusIn Commercial Distribution
Brand NameES™ RETROGRADE FEMORAL NAIL 13mm x 34cm
Version Model Number1393-034
Company DUNS117858154
Company NameADVANCED ORTHOPAEDIC 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665034745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


[00848665034745]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

00848665032703 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, SMALL2024-02-19
00848665032710 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, MEDIUM2024-02-19
00848665032727 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, LARGE2024-02-19
00848665032734 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL2024-02-19
00848665032741 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, MEDIUM2024-02-19
00848665032758 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, LARGE2024-02-19
00848665034066 - BENDING TEMPLATE,MINIMALLY INVASIVE CALCANEAL PLATE, EXTRA SMALL2024-02-19
00848665035988 - VARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm 2024-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.