MODIFIED ARMSTRONG GROMMET

GUDID 10844505012734

MODIFIED ARMSTRONG GROMMET 1.14MM ID WHITE FLUOROPLASTIC PAIR 10 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID10844505012734
NIH Device Record Key6075f873-dd10-434f-9133-6329bef1d70e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFIED ARMSTRONG GROMMET
Version Model Number520-272
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
GS100844505012737 [Primary]
GS110844505012734 [Package]
Contains: 00844505012737
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-03
Device Publish Date2019-09-25

On-Brand Devices [MODIFIED ARMSTRONG GROMMET]

00844505009256MODIFIED ARMSTRONG GROMMET 1.14MM ID, BLUE FLUOROPLASTIC 30 PACK
00844505009249MODIFIED ARMSTRONG GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
10844505012734MODIFIED ARMSTRONG GROMMET 1.14MM ID WHITE FLUOROPLASTIC PAIR 10 PACK
10844505011935MODIFIED ARMSTRONG GROMMET 1.14MM ID WHITE FLUOROPLASTIC PAIR 60 PACK

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