PARTIAL 4MM CENTERED HEAD

GUDID 00844505000437

PARTIAL 4MM CENTERED HEAD 1.12MM ID X 6MM L HA/OTOSIL

Grace Medical, Inc.

Ossicular prosthesis, partial
Primary Device ID00844505000437
NIH Device Record Key0f449d07-5afe-493a-bb6a-3e01a6ffb966
Commercial Distribution StatusIn Commercial Distribution
Brand NamePARTIAL 4MM CENTERED HEAD
Version Model Number271
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
GS100844505000437 [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

Devices Manufactured by Grace Medical, Inc.

00844505014618 - REUTER BOBBIN VENT TUBE2025-02-10 REUTER BOBBIN VENT TUBE W/ HOLES 1.14MM ID FLUOROPLASTIC 60 PACK
10844505014585 - REUTER BOBBIN VENT TUBE2025-02-03 REUTER BOBBIN VENT TUBE W/HOLES 1.14MM ID FLUOROPLASTIC
10844505014592 - REUTER BOBBIN VENT TUBE2025-02-03 REUTER BOBBIN VENT TUBE W/ HOLES 1.14MM ID FLUOROPLASTIC 10 PACK
10844505014608 - REUTER BOBBIN VENT TUBE2025-02-03 REUTER BOBBIN VENT TUBE W/ HOLES 1.14MM ID FLUOROPLASTIC 30 PACK
00844505014335 - CUEVA DISSECTOR2024-11-25 CUEVA NO.1 DISSECTOR, DOUBLE-ENDED, STAINLESS STEEL
00844505014403 - ApollOS2024-05-13 ApollOS™
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

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