AOS SCREW SPACER/ COMPRESSION BOLT FEMORAL NAILS

GUDID 00848665018455

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone washer, non-sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer
Primary Device ID00848665018455
NIH Device Record Key2ed8b3b0-be66-4471-8a40-a3ecb64e4ac5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS SCREW SPACER/ COMPRESSION BOLT FEMORAL NAILS
Version Model Number1326
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
GS100848665018455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


[00848665018455]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-28

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00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH2020-06-08
00848665028041 - T10 Screwdriver, Short2020-06-08
00848665028096 - 3.5mm Calibrated Drill2020-06-08
00848665028119 - AOS 2.6mm Solid Reamer2020-06-08
00848665028782 - T10 Screwdriver, Solid2020-06-08

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