USA Series™ Continuous Flow Operative Hysteroscope System 7 mm

GUDID 00821925002463

GY7-CFH CF Operative Hys-System 7mm 7Fr

Gyrus Acmi, Inc.

Rigid optical hysteroscope

Primary Device ID	00821925002463
NIH Device Record Key	8b658bc2-6e4b-469f-aafe-19db85b9c3db
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Series™ Continuous Flow Operative Hysteroscope System 7 mm
Version Model Number	GY7-CFH
Company DUNS	007198742
Company Name	Gyrus Acmi, 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	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925002463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIH	Hysteroscope (And Accessories)

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

[00821925002463]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-08
Device Publish Date	2016-10-14

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