MYOSURE XL HYSTEROSCOPY SET

GUDID 15420045510333

Hologic, Inc.

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Primary Device ID	15420045510333
NIH Device Record Key	9ba0980f-9198-43b2-8c41-e8c4ce742307
Commercial Distribution Status	In Commercial Distribution
Brand Name	MYOSURE XL HYSTEROSCOPY SET
Version Model Number	50-250XL
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	15420045510333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122563

FDA Product Code

HIH	HYSTEROSCOPE (AND ACCESSORIES)