CANNULATED STRAIGHT AWL WITH T-HANDLE

GUDID 00848665040128

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable
Primary Device ID00848665040128
NIH Device Record Keye6d4f81f-390c-46fc-b204-eeb2850ea24d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCANNULATED STRAIGHT AWL WITH T-HANDLE
Version Model Number0218-200
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 Usefalse
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

Customer Support Contacts

Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com
Phone(310) 533-9966
EmailATI_Regulatory@arthrex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665040128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


[00848665040128]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-17
Device Publish Date2022-05-09

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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

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