ACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)

GUDID 00821925001220

Gyrus Acmi, Inc.

Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer Laparoscopic access cannula seal reducer

• Primary Device ID: 00821925001220
• NIH Device Record Key: 5dc57484-a9b9-4251-b7cb-1f212082aaeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)
• Version Model Number: CS-W7S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00821925001220 [Package]; Contains: 00821925036352; Package: [6 Units]; In Commercial Distribution
GS1	00821925036352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012758

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

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

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)