GUDID 00385640023863

SUMMIT MEDICAL, INC.

Middle ear decompressor, positive pressure
Primary Device ID00385640023863
NIH Device Record Key8beddb76-7b00-463f-90f6-47622b2efefa
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEP-2100A
Company DUNS965484699
Company NameSUMMIT MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640023863 [Primary]
GS110385640023860 [Package]
Package: BOX [12 Units]
In Commercial Distribution
GS120385640023867 [Package]
Package: BOX [48 Units]
In Commercial Distribution
GS130385640023864 [Package]
Package: BOX [48 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJVDevice, Inflation, Middle Ear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-11

Devices Manufactured by SUMMIT MEDICAL, INC.

00385640083782 - INSTRUSAFE2024-11-11
00385640083768 - INSTRUSAFE2024-11-08
00385640083775 - INSTRUSAFE2024-11-08
00385640083737 - INSTRUSAFE2024-11-07
00385640083744 - INSTRUSAFE2024-11-07
00385640083751 - INSTRUSAFE2024-11-07
00385640083720 - INSTRUSAFE2024-11-05
00385640083669 - INSTRUSAFE2024-11-04

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