MODIFIED COLLAR BUTTON VENT TUBE

GUDID 10844505012642

MODIFIED COLLAR BUTTON VENT TUBE 1.27MM ID SILICONE 30 PACK

Grace Medical, Inc.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube
Primary Device ID10844505012642
NIH Device Record Keyee1f6acc-c888-4f28-b305-1d5dc4a47643
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFIED COLLAR BUTTON VENT TUBE
Version Model Number510-243
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
GS100844505012645 [Primary]
GS110844505012642 [Package]
Contains: 00844505012645
Package: [30 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 Number2
Public Version Date2020-05-04
Device Publish Date2019-10-01

Devices Manufactured by Grace Medical, Inc.

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10844505014004 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
10844505014042 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
10844505014080 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 10 PACK
10108445050141 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
10844505014165 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 30 PACK
10844505014189 - ARMSTRONG VENT TUBE2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK
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