GRACE BUCKET HANDLE OFFSET

GUDID 00844505006651

GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 5.50MM L TITANIUM/NITINOL HANDLE

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505006651
NIH Device Record Key6fb606ea-cd83-4ee1-874e-6b2d628fd6b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRACE BUCKET HANDLE OFFSET
Version Model Number430-550
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
GS100844505006651 [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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