EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.

GUDID 00844505012249

EndoEar™ ENDOSCOPE 3.0 MM x 150 MM 0°

Grace Medical, Inc.

Otoscope, endoscopic
Primary Device ID00844505012249
NIH Device Record Key8d8e4d2e-30d4-4089-ab1f-54fe3b60ed73
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.
Version Model NumberEE-0300
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505012249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00844505012249]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-13
Device Publish Date2019-12-05

Devices Manufactured by Grace Medical, Inc.

00844505014694 - SKULL BASE2025-10-06 SKULL BASE ROUND KNIFE ANGLED 45° STAINLESS STEEL
00844505014700 - SKULL BASE2025-10-06 RIGHT ANGLE SIZING ROD STAINLESS STEEL
00844505014717 - SKULL BASE2025-10-06 DOUBLE-ENDED DISSECTOR STRAIGHT CUEVA AND SPOON STAINLESS STEEL
00844505014724 - SKULL BASE2025-10-06 EXTENDED THOMASSIN DISSECTOR DOUBLE-ENDED STAINLESS STEEL
00844505014502 - TITANIUM PISTON2025-09-26 TITANIUM PISTON 0.6MM DIA X 5.75MM L TITANIUM/RIBBON
00844505014687 - GRACE MEDICAL FLUOROPLASTIC PISTON2025-09-26 FLUOROPLASTIC PISTON 0.6MM DIA X 5.50MM L
00844505014489 - ECLIPSE PISTON2025-08-13 ECLIPSE PISTON 0.5MM DIA X 3.50MM L NITINOL/FLUOROPLASTIC
00844505014519 - TITANIUM PISTON2025-08-13 TITANIUM PISTON 0.4MM DIA X 5.75MM L TITANIUM/RIBBON
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.