00385640033701 Medical Device Identification

GUDID 00385640033701

Ear wick, non-biodegradable

Primary Device ID	00385640033701
NIH Device Record Key	6a8e29b0-ba2e-40a0-9811-a95ffb5fec8a
Commercial Distribution Status	In Commercial Distribution
Version Model Number	J-1084
Company DUNS	965484699
Company Name	SUMMIT MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00385640033701 [Primary]
GS1	10385640033708 [Package] Package: Box [50 Units] In Commercial Distribution

Ear Wick

Steralize Prior To Use	false
Device Is Sterile	true