COMFORT T-HANDLE, CANNULATED, LARGE HUDSON ADAPTER

GUDID 00848665037517

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

Primary Device ID	00848665037517
NIH Device Record Key	dbcd18a2-136f-4b55-a248-5138dab7d7c1
Commercial Distribution Status	In Commercial Distribution
Brand Name	COMFORT T-HANDLE, CANNULATED, LARGE HUDSON ADAPTER
Version Model Number	0468-100
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	false
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	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665037517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K021008

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories