BOJRAB TINY TRIUNE

GUDID 00844505011662

BOJRAB TINY TRIUNE 0.76MM ID SILICONE, 80 DUROMETER 5 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505011662
NIH Device Record Key68115fec-ba5b-4394-9bb0-f0c6e3b81dfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBOJRAB TINY TRIUNE
Version Model Number510-511
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
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
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505011662 [Primary]
GS110844505011669 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTube, Tympanostomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-08
Device Publish Date2018-01-26

Devices Manufactured by Grace Medical, Inc.

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
00844505014564 - GRACE MEDICAL FLUOROPLASTIC PISTON2025-08-13 FLUOROPLASTIC PISTON 0.6MM DIA X 4.75MM L
00844505014670 - GRACE MEDICAL FLUOROPLASTIC PISTON2025-08-13 FLUOROPLASTIC PISTON 0.6MM DIA X 5.75MM L
00844505014663 - OFFSET TITANIUM WILDCAT ALTO2025-07-25 OFFSET TITANIUM WILDCAT ALTO™ SIZERS INCLUDED TITANIUM/SILICONE
00844505014649 - NYTEBYTE2025-07-10 OFFSET ALTO NYTEBYTE PARTIAL SIZERS INCLUDED TITANIUM/NITINOL/SILICONE
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

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