00385640023849 Medical Device Identification

GUDID 00385640023849

SUMMIT MEDICAL, INC.

Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure

Primary Device ID	00385640023849
NIH Device Record Key	737a7b52-6e21-443c-9da7-e0a0948c3c9c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	EP-2100
Company DUNS	965484699
Company Name	SUMMIT MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640023849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K073401

FDA Product Code

MJV	Device, Inflation, Middle Ear

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-11

Devices Manufactured by SUMMIT MEDICAL, INC.

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