AEH-4 LITHOTRIPSY SYSTEM,110V

GUDID 00821925008496

AEH-4 LITHOTRIPSY SYSTEM,110V

Gyrus Acmi, Inc.

Electrohydraulic lithotripsy system

Primary Device ID	00821925008496
NIH Device Record Key	66fb9db6-f657-4838-aae7-eb3a96ca2eae
Commercial Distribution Status	In Commercial Distribution
Brand Name	AEH-4 LITHOTRIPSY SYSTEM,110V
Version Model Number	AEH-4
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	false
Serial Number	true
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	00821925008496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K923822

FDA Product Code

FFK	Lithotriptor, electro-hydraulic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

[00821925008496]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-13

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