WILDCAT FIXED LENGTH TOTAL, HOLLOW

GUDID 00844505008679

WILDCAT FIXED LENGTH TOTAL, HOLLOW 3.00MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total

Primary Device ID	00844505008679
NIH Device Record Key	ad96abb9-2545-48c5-a4d3-27ccd958e3f0
Commercial Distribution Status	In Commercial Distribution
Brand Name	WILDCAT FIXED LENGTH TOTAL, HOLLOW
Version Model Number	706-300
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

Customer Support Contacts

Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com
Phone	+1(866)472-2363
Email	info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505008679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K061853

FDA Product Code

ETA	REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-02-18

On-Brand Devices [WILDCAT FIXED LENGTH TOTAL, HOLLOW]

00844505008723	WILDCAT FIXED LENGTH TOTAL, HOLLOW 5.50MM LENGTH TITANIUM
00844505008716	WILDCAT FIXED LENGTH TOTAL, HOLLOW 5.00MM LENGTH TITANIUM
00844505008709	WILDCAT FIXED LENGTH TOTAL, HOLLOW 4.50MM LENGTH TITANIUM
00844505008693	WILDCAT FIXED LENGTH TOTAL, HOLLOW 4.00MM LENGTH TITANIUM
00844505008686	WILDCAT FIXED LENGTH TOTAL, HOLLOW 3.50MM LENGTH TITANIUM
00844505008679	WILDCAT FIXED LENGTH TOTAL, HOLLOW 3.00MM LENGTH TITANIUM