Sterishot II Elite Kit

Basic Information

• Brand Name: Sterishot II Elite Kit
• Primary DI: 15055515602371
• Version / Model: AVM-954
• Catalog Number: AVM-954
• Company Name: FEMCARE LIMITED
• Labeler DUNS: 500218573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-14
• Public Version: 2
• Public Version Date: 2021-03-08
• Public Version Status: Update
• Public Device Record Key: b0fe989d-01b1-432d-ad8f-012a4b95ea7b

Device Description

Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator, 8mm Bladeless Trocar and one pair of Filshie® Clips.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNH	Device, Occlusion, Tubal, Contraceptive	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	15055515602371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P920046	008

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place