SHEPARD GROMMET VENT TUBE

GUDID 00844505004169

SHEPARD GROMMET VENT TUBE W/WIRE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505004169
NIH Device Record Keyd0fdcb6c-1590-40e8-90b3-6b53c9e0254c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHEPARD GROMMET VENT TUBE
Version Model Number525-121W
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505004169 [Primary]
GS110844505004166 [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 Date2019-08-14
Device Publish Date2016-02-18

On-Brand Devices [SHEPARD GROMMET VENT TUBE]

00844505008457SHEPARD GROMMET VENT TUBE 1.02MM ID - BLUE FLUOROPLASTIC 30 PACK
00844505008426SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID - BLUE FLUOROPLASTIC 30 PACK
00844505008280SHEPARD GROMMET VENT TUBE 1.02MM ID - FLUOROPLASTIC PAIR 60 PACK
00844505008259SHEPARD GROMMET VENT TUBE 1.02MM ID - FLUOROPLASTIC 30 PACK
00844505004206SHEPARD GROMMET VENT TUBE W/WIRE 1.14MM ID - BLUE FLUOROPLASTIC PAIR 60 PACK
00844505004190SHEPARD GROMMET VENT TUBE 1.14MM ID - BLUE FLUOROPLASTIC PAIR 60 PACK
00844505004183SHEPARD GROMMET VENT TUBE W/WIRE 1.14MM ID BLUE FLUOROPLASTIC/SS 30 PACK
00844505004176SHEPARD GROMMET VENT TUBE 1.14MM ID - BLUE FLUOROPLASTIC 30 PACK
00844505004169SHEPARD GROMMET VENT TUBE W/WIRE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
00844505004152SHEPARD GROMMET VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
00844505004138SHEPARD GROMMET VENT TUBE W/WIRE 1.02MM ID BLUE FLUOROPLASTIC 5 PACK
00844505004121SHEPARD GROMMET VENT TUBE 1.02MM ID BLUE FLUOROPLASTIC 5 PACK
00844505004084SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
00844505003896SHEPARD GROMMET VENT TUBE 1.14MM ID FLUOROPLASTIC PAIR 10 PACK
00844505003889SHEPARD GROMMET VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
00844505003872SHEPARD GROMMET VENT TUBE 1.02MM ID FLUOROPLASTIC PAIR 10 PACK
00844505003865SHEPARD GROMMET VENT TUBE 1.02MM ID FLUOROPLASTIC 5 PACK
00844505003711SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID FLUOROPLASTIC PAIR 10 PACK
00844505003704SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID FLUOROPLASTIC 5 PACK
00844505003698SHEPARD GROMMET VENT TUBE W/TAB 1.02MM ID FLUOROPLASTIC PAIR 10 PACK
00844505003681SHEPARD GROMMET VENT TUBE W/TAB 1.02MM ID FLUOROPLASTIC 5 PACK
00844505003469SHEPARD GROMMET VENT TUBE 1.02MM ID SILICONE 5 PACK
00844505002752SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID SILICONE PAIR 10 PACK
00844505002745SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID SILICONE 5 PACK
00844505002738SHEPARD GROMMET VENT TUBE W/TAB 1.02MM ID SILICONE PAIR 10 PACK
00844505002714SHEPARD GROMMET VENT TUBE W/TAB 1.02MM ID SILICONE 5 PACK
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.