00385640023863 Medical Device Identification

GUDID 00385640023863

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 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 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 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 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 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	00385640023863
NIH Device Record Key	8beddb76-7b00-463f-90f6-47622b2efefa
Commercial Distribution Status	In Commercial Distribution
Version Model Number	EP-2100A
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	00385640023863 [Primary]
GS1	10385640023860 [Package] Package: BOX [12 Units] In Commercial Distribution
GS1	20385640023867 [Package] Package: BOX [48 Units] In Commercial Distribution
GS1	30385640023864 [Package] Package: BOX [48 Units] In Commercial Distribution

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

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