LID, 3.5mm SCREW CADDY

GUDID 00848665031812

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Instrument tray, reusable
Primary Device ID00848665031812
NIH Device Record Key21170f4b-aed4-4a64-b20e-c608b6db6423
Commercial Distribution StatusIn Commercial Distribution
Brand NameLID, 3.5mm SCREW CADDY
Version Model Number9912-007
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
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
GS100848665031812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


[00848665031812]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-14
Device Publish Date2022-06-06

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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