OWENS ASSURE ALTO TOTAL W/INTEGRATED SHOE

GUDID 00844505002097

Ossicular prosthesis, total

Primary Device ID	00844505002097
NIH Device Record Key	89cb5435-72d1-402d-ad08-0771d666f2ca
Commercial Distribution Status	In Commercial Distribution
Brand Name	OWENS ASSURE ALTO TOTAL W/INTEGRATED SHOE
Version Model Number	602
Company DUNS	030849173
Company Name	Grace Medical, Inc.
Device Count	1
DM Exempt	true
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	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00844505002097 [Primary]

ETA	REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Steralize Prior To Use	false
Device Is Sterile	true

00844505002097	OWENS ASSURE ALTO TOTAL W/INTEGRATED SHOE - SIZERS INCLUDED TITANIUM/SILICONE
00844505013529	OWENS ASSURE ALTO TOTAL W/INTEGRATED SHOE - SIZERS INCLUDED TITANIUM/SILICONE