GRAACE MEDICAL T-TUBE

GUDID 00844505003001

T-TUBE 1.14MM ID X 12MM LENGTH PC SILICONE 5 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505003001
NIH Device Record Keyf64ec8d9-acda-4a0c-be02-b1ed840b2945
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRAACE MEDICAL T-TUBE
Version Model Number510-101C
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100844505003001 [Primary]
GS110844505003008 [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 Number5
Public Version Date2020-03-18
Device Publish Date2016-02-18

On-Brand Devices [GRAACE MEDICAL T-TUBE]

00844505003032T-TUBE 1.27MM ID X 6MM LENGTH PC SILICONE 5 PACK
00844505003001T-TUBE 1.14MM ID X 12MM LENGTH PC SILICONE 5 PACK

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