GRACE BUCKET HANDLE OFFSET

GUDID 00844505001717

GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.75MM L TITANIUM/NITINOL HANDLE

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505001717
NIH Device Record Key301eab83-4984-49af-a86a-e2ba2659fba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRACE BUCKET HANDLE OFFSET
Version Model Number430-475
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505001717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-13
Device Publish Date2016-02-18

On-Brand Devices [GRACE BUCKET HANDLE OFFSET]

00844505006668GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 6.00MM L TITANIUM/NITINOL HANDLE
00844505006651GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 5.50MM L TITANIUM/NITINOL HANDLE
00844505001724GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 5.00MM L TITANIUM/NITINOL HANDLE
00844505001717GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.75MM L TITANIUM/NITINOL HANDLE
00844505001700GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.50MM L TITANIUM/NITINOL HANDLE
00844505001694GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.25MM L TITANIUM/NITINOL HANDLE
00844505001687GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.00MM L TITANIUM/NITINOL HANDLE

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