Falope-Ring® Bands

GUDID 00821925032972

Gyrus Acmi, Inc.

Fallopian tube clip/band

• Primary Device ID: 00821925032972
• NIH Device Record Key: e6794cff-1131-451d-ba49-d3790250cd73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Falope-Ring® Bands
• Version Model Number: FRB-30
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925008946 [Package]; Package: [30 Units]; In Commercial Distribution
GS1	00821925032972 [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

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