FRISBEE PARTIAL

GUDID 00844505005760

FRISBEE PARTIAL 1.50MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505005760
NIH Device Record Key7888baba-7c8b-4b66-8f04-ee58a1ff55f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRISBEE PARTIAL
Version Model Number750-150
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
GS100844505005760 [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 Date2020-03-30
Device Publish Date2016-02-18

On-Brand Devices [FRISBEE PARTIAL]

00844505008808FRISBEE PARTIAL 2.0MM LENGTH TITANIUM
00844505005760FRISBEE PARTIAL 1.50MM LENGTH TITANIUM
00844505005753FRISBEE PARTIAL 1.00MM LENGTH TITANIUM
00844505005746FRISBEE PARTIAL 0.5MM LENGTH TITANIUM

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