ROBINSON BUCKET HANDLE

GUDID 00844505001243

ROBINSON BUCKET HANDLE 0.6MM DIA X 3.50MM L TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505001243
NIH Device Record Key606b1cb8-4203-44b1-9f1f-60d50fc30c63
Commercial Distribution StatusIn Commercial Distribution
Brand NameROBINSON BUCKET HANDLE
Version Model Number422-350
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
GS100844505001243 [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 [ROBINSON BUCKET HANDLE]

00844505001403ROBINSON BUCKET HANDLE 0.8MM DIA X 5.00MM L TITANIUM
00844505001397ROBINSON BUCKET HANDLE 0.8MM DIA X 4.50MM L TITANIUM
00844505001380ROBINSON BUCKET HANDLE 0.8MM DIA X 4.25MM L TITANIUM
00844505001373ROBINSON BUCKET HANDLE 0.8MM DIA X 4.00MM L TITANIUM
00844505001304ROBINSON BUCKET HANDLE 0.6MM DIA X 5.00MM L TITANIUM
00844505001298ROBINSON BUCKET HANDLE 0.6MM DIA X 4.75MM L TITANIUM
00844505001281ROBINSON BUCKET HANDLE 0.6MM DIA X 4.50MM L TITANIUM
00844505001274ROBINSON BUCKET HANDLE 0.6MM DIA X 4.25MM L TITANIUM
00844505001267ROBINSON BUCKET HANDLE 0.6MM DIA X 4.00MM L TITANIUM
00844505001250ROBINSON BUCKET HANDLE 0.6MM DIA X 3.75MM L TITANIUM
00844505001243ROBINSON BUCKET HANDLE 0.6MM DIA X 3.50MM L TITANIUM
00844505001168ROBINSON BUCKET HANDLE 0.4MM DIA X 5.00MM L TITANIUM
00844505001151ROBINSON BUCKET HANDLE 0.4MM DIA X 4.75MM L TITANIUM
00844505001144ROBINSON BUCKET HANDLE 0.4MM DIA X 4.50MM L TITANIUM
00844505001137ROBINSON BUCKET HANDLE 0.4MM DIA X 4.25MM L TITANIUM
00844505001120ROBINSON BUCKET HANDLE 0.4MM DIA X 4.00MM L TITANIUM
00844505001113ROBINSON BUCKET HANDLE 0.4MM DIA X 3.75MM L TITANIUM
00844505001106ROBINSON BUCKET HANDLE 0.4MM DIA X 3.50MM L TITANIUM

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