Handyvak Locking Syringe

Basic Information

• Brand Name: Handyvak Locking Syringe
• Primary DI: 00888937000610
• Version / Model: MX500
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-18
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 821088cf-e665-4c27-bb3f-26976d3d4bf8

Device Description

60cc

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: No
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11531	Endometrial biopsy kit	A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937000614	GS1		10	In Commercial Distribution
Primary	00888937000610	GS1

Premarket Submissions

Submission Number	Supplement Number
K760264	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			60cc