MyoSure Rod Lens Hysteroscope Instrument Tray

GUDID 15420045510241

Hologic, Inc.

Instrument tray

Primary Device ID	15420045510241
NIH Device Record Key	d786d57a-3144-43b9-a494-91ff56195a30
Commercial Distribution Status	In Commercial Distribution
Brand Name	MyoSure Rod Lens Hysteroscope Instrument Tray
Version Model Number	40-903
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	15420045510241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121280

FDA Product Code

KCT	Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

[15420045510241]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-11-23
Device Publish Date	2018-10-23

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