GUDID 00385640026703

SUMMIT MEDICAL, INC.

Tympanostomy tube
Primary Device ID00385640026703
NIH Device Record Key853ec98f-fce1-449c-b5c5-4167dc8223b7
Commercial Distribution Discontinuation2020-04-27
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberVT-0401-01-E
Company DUNS965484699
Company NameSUMMIT MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640026703 [Primary]

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 Date2020-04-28
Device Publish Date2017-01-26

Devices Manufactured by SUMMIT MEDICAL, INC.

00385640083881 - INSTRUSAFE2024-11-19
00385640083898 - INSTRUSAFE2024-11-19
00385640083874 - INSTRUSAFE2024-11-18
00385640083836 - INSTRUSAFE2024-11-15
00385640083843 - INSTRUSAFE2024-11-15
00385640083850 - INSTRUSAFE2024-11-15
00385640083867 - INSTRUSAFE2024-11-15
00385640083805 - INSTRUSAFE2024-11-14

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