Gyrus ACMI

GUDID 00821925028913

Single Incision Inner Tube Assembly

Gyrus Acmi, Inc.

Fallopian tube clip/band

• Primary Device ID: 00821925028913
• NIH Device Record Key: 5f019101-a234-4352-aa58-d13d84398d4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gyrus ACMI
• Version Model Number: 000948-501
• 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	00821925028913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P870076

FDA Product Code

• KNH: Laparoscopic Contraceptive Tubal Occlusion Device

Sterilization

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

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

[00821925028913]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-22
• Device Publish Date: 2024-07-12

On-Brand Devices [Gyrus ACMI]

• 00821925038356: Ellik Tubing For Ellik/Toomey Adapters
• 00821925015708: SCHUKNECHT CRESCENT FLUOROPLASTIC
• 00821925044630: DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN
• 00821925028913: Single Incision Inner Tube Assembly