Gyrus ACMI

Basic Information

• Brand Name: Gyrus ACMI
• Primary DI: 00821925028913
• Version / Model: 000948-501
• Company Name: Gyrus ACMI, LLC
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-12
• Public Version: 2
• Public Version Date: 2024-09-02
• Public Version Status: Update
• Public Device Record Key: 5f019101-a234-4352-aa58-d13d84398d4c

Device Description

Single Incision Inner Tube Assembly

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Obstetrics/Gynecology	884.5380	3

GMDN Terms

Code	Name	Definition	Implantable	Status
33598	Fallopian tube clip/band	An implantable device applied externally to the fallopian tube(s) to constrict the tube and prevent the passage of ova. It is typically used during tubal ligation procedures and functions as a contraceptive device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925028913	GS1

Premarket Submissions

Submission Number	Supplement Number
P870076	000