ES™ RETROGRADE FEMORAL NAIL 10mm x 36cm

GUDID 00848665034424

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Femur nail, non-sterile
Primary Device ID00848665034424
NIH Device Record Key084b2ee7-3f0b-45cc-9733-6f9c5f3a8246
Commercial Distribution StatusIn Commercial Distribution
Brand NameES™ RETROGRADE FEMORAL NAIL 10mm x 36cm
Version Model Number1390-036
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
GS100848665034424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

Moist Heat or Steam Sterilization


[00848665034424]

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

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00848665032741 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, MEDIUM2024-02-19
00848665032758 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, LARGE2024-02-19

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