Adapter PK Working Element Gyrus® PK™ SuperPulse™ System

GUDID 00821925007772

Gyrus Acmi, Inc.

Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope

• Primary Device ID: 00821925007772
• NIH Device Record Key: 5e888408-c637-447b-8067-fc62d4a6cffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adapter PK Working Element Gyrus® PK™ SuperPulse™ System
• Version Model Number: PKWE-AD
• 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	00821925007772 [Package]; Contains: 00821925038547; Package: [5 Units]; In Commercial Distribution
GS1	00821925038547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021166

FDA Product Code

• FBO: CYSTOURETHROSCOPE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

Moist Heat or Steam Sterilization

[00821925007772]

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: 2016-10-18

Devices Manufactured by Gyrus Acmi, Inc.

• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)