10.5mm CANNULATED ENTRY REAMER

GUDID 00848665032321

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Bone-resection orthopaedic reamer, reusable
Primary Device ID00848665032321
NIH Device Record Key3a649dff-ef6c-438e-a8b0-f4a99d099497
Commercial Distribution StatusIn Commercial Distribution
Brand Name10.5mm CANNULATED ENTRY REAMER
Version Model Number0221-100
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

Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665032321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


[00848665032321]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-17
Device Publish Date2022-02-09

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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00848665029017 - SEMI-TUBULAR PLATE, 17-HOLE2024-11-13
00848665029024 - SEMI-TUBULAR PLATE, 19-HOLE2024-11-13
00848665029031 - SEMI-TUBULAR PLATE, 21-HOLE2024-11-13
00848665029048 - STRAIGHT PLATE, 13-HOLE2024-11-13
00848665029055 - STRAIGHT PLATE, 15-HOLE2024-11-13
00848665029062 - STRAIGHT PLATE, 17-HOLE2024-11-13

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