00385640061926 Medical Device Identification

GUDID 00385640061926

Tympanostomy tube

Primary Device ID	00385640061926
NIH Device Record Key	cce4bd2e-db6e-4af8-8b73-80f483724fc8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	ET-PSDT-1
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00385640061926 [Primary]
GS1	10385640061923 [Package] Package: Box [10 Units] In Commercial Distribution

ETD	Tube, Tympanostomy

Steralize Prior To Use	false
Device Is Sterile	true