WILDCAT FIXED LENGTH TOTAL

GUDID 00844505008730

WILDCAT FIXED LENGTH TOTAL 3.00MM LENGTH TITANIUM

Grace Medical, Inc.

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Primary Device ID	00844505008730
NIH Device Record Key	ff5464b8-966f-4dd5-8876-7ca9f75c9156
Commercial Distribution Status	In Commercial Distribution
Brand Name	WILDCAT FIXED LENGTH TOTAL
Version Model Number	707-300
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	00844505008730 [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]

00844505008785	WILDCAT FIXED LENGTH TOTAL 5.50MM LENGTH TITANIUM
00844505008778	WILDCAT FIXED LENGTH TOTAL 5.00MM LENGTH TITANIUM
00844505008761	WILDCAT FIXED LENGTH TOTAL 4.50MM LENGTH TITANIUM
00844505008754	WILDCAT FIXED LENGTH TOTAL 3.50MM LENGTH TITANIUM
00844505008747	WILDCAT FIXED LENGTH TOTAL 4.00MM LENGTH TITANIIUM
00844505008730	WILDCAT FIXED LENGTH TOTAL 3.00MM LENGTH TITANIUM