MYOSURE HYSTEROSCOPY SET

GUDID 15420045510326

Hologic, Inc.

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Primary Device ID	15420045510326
NIH Device Record Key	5671a4ae-f213-41f6-9188-167131ede194
Commercial Distribution Status	In Commercial Distribution
Brand Name	MYOSURE HYSTEROSCOPY SET
Version Model Number	40-250
Company DUNS	018925968
Company Name	Hologic, 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	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045510326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K091465

FDA Product Code

HIH	HYSTEROSCOPE (AND ACCESSORIES)