Disposable Falope Ring® Band Applicator Kit with 8mm disposable Trocar

GUDID 00821925032996

Gyrus Acmi, Inc.

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• Primary Device ID: 00821925032996
• NIH Device Record Key: 2d9e8b2b-e6d4-48d6-b553-58db7c0c2931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Falope Ring® Band Applicator Kit with 8mm disposable Trocar
• Version Model Number: 005280-901
• 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: true
• 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

Customer Support Contacts

• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx
• Phone: 1-888-524-7266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925000124 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	00821925032996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P870076

FDA Product Code

• KNH: Device, Occlusion, Tubal, Contraceptive

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: 2014-09-19

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)