MODIFIED ARMSTRONG GROMMET

GUDID 00844505009249

MODIFIED ARMSTRONG GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505009249
NIH Device Record Key2e3486c2-bb64-4952-beb6-4e128064d57f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFIED ARMSTRONG GROMMET
Version Model Number525-181
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
GS100844505009249 [Primary]
GS110844505009246 [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 [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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