SHOCKPULSE LITHOTRIPSY WRENCH

GUDID 00821925039445

Gyrus Acmi, Inc.

Electrohydraulic/pneumatic lithotripsy system probe, urinary, reusable

Primary Device ID	00821925039445
NIH Device Record Key	a823e2b1-d0c4-45c2-920f-a1429cd08808
Commercial Distribution Status	In Commercial Distribution
Brand Name	SHOCKPULSE LITHOTRIPSY WRENCH
Version Model Number	SPL-W
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	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	00821925039445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142428

FDA Product Code

FEO	Lithotriptor, ultrasonic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

[00821925039445]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-02-14
Device Publish Date	2018-09-14

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