Sterishot (Femcare) for Minilaparotomy

Basic Information

• Brand Name: Sterishot (Femcare) for Minilaparotomy
• Primary DI: 15055515602340
• Version / Model: AVM-600M
• Catalog Number: AVM-600M
• Company Name: FEMCARE LIMITED
• Labeler DUNS: 500218573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-15
• Public Version: 1
• Public Version Date: 2023-05-23
• Public Version Status: New
• Public Device Record Key: 0caa6e5b-4264-4ada-86ed-0f8323fae572

Device Description

Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator ONLY as part of a kit.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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	15055515602340	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P920046	010

Storage Conditions

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