UNIVERSAL PROSTHESIS

GUDID 00844505000222

UNIVERSAL PROSTHESIS OTOSIL/HA, FIXED HEAD, TOTAL & PARTIAL SHAFTS SUPPLIED

Grace Medical, Inc.

Ossicular prosthesis, total
Primary Device ID00844505000222
NIH Device Record Key54769b35-9fc2-4d76-9196-2ade449820ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL PROSTHESIS
Version Model Number193
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
GS100844505000222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-18
Device Publish Date2016-02-18

Devices Manufactured by Grace Medical, Inc.

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10844505014004 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
10844505014042 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
10844505014080 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 10 PACK
10108445050141 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
10844505014165 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 30 PACK
10844505014189 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK

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