PRECISE CENTERED TOTAL 1.50MM L

GUDID 00844505011167

PRECISE CENTERED TOTAL 1.50MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total
Primary Device ID00844505011167
NIH Device Record Key617a5eb8-770a-432e-bde1-9f029dfa430d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECISE CENTERED TOTAL 1.50MM L
Version Model Number705-150
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
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505011167 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-04-07

Devices Manufactured by Grace Medical, Inc.

10844505014394 - TOUMA VENT TUBE W/ TAB2024-01-31 MODIFIED TOUMA VENT TUBE W/ TAB 1.27MM ID SILICONE
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
10844505014240 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 60 PACK
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.