2.5mm HEX SCREWDRIVER

GUDID 00848665032345

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile Surgical screwdriver, single-use, non-sterile

Primary Device ID	00848665032345
NIH Device Record Key	7182f97a-2d5c-4861-8118-cdb54257b9a6
Commercial Distribution Status	In Commercial Distribution
Brand Name	2.5mm HEX SCREWDRIVER
Version Model Number	0416-200
Company DUNS	117858154
Company Name	ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com
Phone	310-533-9966
Email	ATI_Regulatory@arthrex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665032345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K050241

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories