BARTELS BUCKET HANDLE

GUDID 00844505001564

BARTELS BUCKET HANDLE 0.4MM DIA X 3.75MM L TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505001564
NIH Device Record Key56de3720-b368-46d5-b048-5565bfefe963
Commercial Distribution StatusIn Commercial Distribution
Brand NameBARTELS BUCKET HANDLE
Version Model Number427-375
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
GS100844505001564 [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 [BARTELS BUCKET HANDLE]

00844505001618BARTELS BUCKET HANDLE 0.4MM DIA X 5.00MM L TITANIUM
00844505001601BARTELS BUCKET HANDLE 0.4MM DIA X 4.75MM L TITANIUM
00844505001595BARTELS BUCKET HANDLE 0.4MM DIA X 4.50MM L TITANIUM
00844505001588BARTELS BUCKET HANDLE 0.4MM DIA X 4.25MM L TITANIUM
00844505001571BARTELS BUCKET HANDLE 0.4MM DIA X 4.00MM L TITANIUM
00844505001564BARTELS BUCKET HANDLE 0.4MM DIA X 3.75MM L TITANIUM
00844505001557BARTELS BUCKET HANDLE 0.4MM DIA X 3.50MM L TITANIUM
00844505001540BARTELS BUCKET HANDLE 0.6MM DIA X 5.00MM L TITANIUM
00844505001533BARTELS BUCKET HANDLE 0.6MM DIA X 4.75MM L TITANIUM
00844505001526BARTELS BUCKET HANDLE 0.6MM DIA X 4.50MM L TITANIUM
00844505001519BARTELS BUCKET HANDLE 0.6MM DIA X 4.25MM L TITANIUM
00844505001502BARTELS BUCKET HANDLE 0.6MM DIA X 4.00MM L TITANIUM
00844505001496BARTELS BUCKET HANDLE 0.6MM DIA X 3.75MM L TITANIUM
00844505001489BARTELS BUCKET HANDLE 0.6MM DIA X 3.50MM L TITANIUM

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