PRECISE BYTE

GUDID 00844505009454

PRECISE CENTERED BYTE PARTIAL 2.25MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505009454
NIH Device Record Key3f78227c-cf84-4bea-8bc9-b776e49a2011
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE BYTE
Version Model Number752-225
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
GS100844505009454 [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 Date2020-04-27
Device Publish Date2016-02-18

On-Brand Devices [PRECISE BYTE]

00844505009461PRECISE CENTERED BYTE PARTIAL 2.50MM LENGTH TITANIUM
00844505009454PRECISE CENTERED BYTE PARTIAL 2.25MM LENGTH TITANIUM
00844505009447PRECISE CENTERED BYTE PARTIAL 2.00MM LENGTH TITANIUM
00844505009430PRECISE CENTERED BYTE PARTIAL 1.75MM LENGTH TITANIUM
00844505009423PRECISE CENTERED BYTE PARTIAL 1.50MM LENGTH TITANIUM
00844505009416PRECISE CENTERED BYTE PARTIAL 1.25MM LENGTH TITANIUM
00844505009409PRECISE CENTERED BYTE PARTIAL 1.00MM LENGTH TITANIUM
00844505009393PRECISE CENTERED BYTE PARTIAL 0.75MM LENGTH TITANIUM

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