GUDID 00385640002431

SUMMIT MEDICAL, INC.

Middle ear decompressor, positive pressure
Primary Device ID00385640002431
NIH Device Record Key3cf8a190-0408-47dc-b77f-33e45cd1047e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEP-1010
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
GS100385640002431 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-26
Device Publish Date2021-05-18

Devices Manufactured by SUMMIT MEDICAL, INC.

00385640083935 - INSTRUSAFE2024-11-21
00385640083904 - INSTRUSAFE2024-11-20
00385640083911 - INSTRUSAFE2024-11-20
00385640083928 - INSTRUSAFE2024-11-20
00385640083881 - INSTRUSAFE2024-11-19
00385640083898 - INSTRUSAFE2024-11-19
00385640083874 - INSTRUSAFE2024-11-18
00385640083836 - INSTRUSAFE2024-11-15

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