HA FRISBEE PARTIAL

GUDID 00844505006781

HA FRISBEE PARTIAL 1.00MM LENGTH HA

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505006781
NIH Device Record Key8e038768-c05a-477d-bca3-75ac17bac96e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA FRISBEE PARTIAL
Version Model Number749-100
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100844505006781 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-02-18

On-Brand Devices [HA FRISBEE PARTIAL]

00844505008792HA FRISBEE PARTIAL 2.00MM LENGTH HA
00844505006798HA FRISBEE PARTIAL 1.50MM LENGTH HA
00844505006781HA FRISBEE PARTIAL 1.00MM LENGTH HA
00844505006774HA FRISBEE PARTIAL 0.5MM LENGTH HA

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