DRILL, Ø2.8mm

GUDID 00848665031843

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Fluted surgical drill bit, single-use
Primary Device ID00848665031843
NIH Device Record Key761190fd-1f13-4d9a-9ba7-394c30779c8d
Commercial Distribution Discontinuation2025-10-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDRILL, Ø2.8mm
Version Model Number4009-200
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665031843 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


[00848665031843]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-05
Device Publish Date2023-01-31

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

00848665031829 - TARGETING MODULE, HUMERAL NAIL2026-01-05
00848665031843 - DRILL, Ø2.8mm2026-01-05
00848665031843 - DRILL, Ø2.8mm2026-01-05
00848665032840 - RADIOLUCENT TARGETING ARM, CALCANEAL PLATE, LEFT, SMALL2026-01-05
00848665032857 - RADIOLUCENT TARGETING ARM, CALCANEAL PLATE, LEFT, MEDIUM2026-01-05
00848665032864 - RADIOLUCENT TARGETING ARM, CALCANEAL PLATE, LEFT, LARGE2026-01-05
00848665032871 - RADIOLUCENT TARGETING ARM, CALCANEAL PLATE, RIGHT, SMALL2026-01-05
00848665032888 - RADIOLUCENT TARGETING ARM, CALCANEAL PLATE, RIGHT, MEDIUM2026-01-05
00848665028720 - GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 48cm x 130°2026-01-01

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