GRACE MEDICAL T-TUBE

GUDID 00844505003049

T-TUBE 1.27MM ID X 6MM LENGTH SILICONE PAIR 10 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505003049
NIH Device Record Key97cc7192-c9be-4112-bf8b-832d8ae7b337
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRACE MEDICAL T-TUBE
Version Model Number510-112
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505003049 [Primary]
GS110844505003046 [Package]
Package: [10 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 Date2019-08-15
Device Publish Date2016-02-18

On-Brand Devices [GRACE MEDICAL T-TUBE]

00844505003049T-TUBE 1.27MM ID X 6MM LENGTH SILICONE PAIR 10 PACK
00844505003025T-TUBE 1.14MM ID X 12MM LENGTH SILICONE PAIR 10 PACK
00844505003018T-TUBE 1.27MM ID X 6MM LENGTH SILICONE 5 PACK
00844505002998T-TUBE 1.14MM ID X 12MM LENGTH SILICONE 5 PACK

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