TOUMA VENT TUBE W/ TAB

GUDID 00844505007801

TOUMA VENT TUBE W/ TAB 1.14MM ID SILICONE 5 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505007801
NIH Device Record Key0215997d-f82e-4def-9af0-af4f7a82fe55
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOUMA VENT TUBE W/ TAB
Version Model Number510-501
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
GS100844505007801 [Primary]
GS110844505007808 [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 Date2016-02-18

On-Brand Devices [TOUMA VENT TUBE W/ TAB]

00844505011679TOUMA VENT TUBE W/ TAB 1.14 MM ID SILICONE, 50 DUROMETER 5 PACK
00844505010245TOUMA VENT TUBE W/ TAB 1.14MM ID PC SILICONE 5 PACK
00844505007801TOUMA VENT TUBE W/ TAB 1.14MM ID SILICONE 5 PACK
10844505014394MODIFIED TOUMA VENT TUBE W/ TAB 1.27MM ID SILICONE

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