MedGyn Disposable Amnio Hook

Basic Information

• Brand Name: MedGyn Disposable Amnio Hook
• Primary DI: M803020301
• Version / Model: Amniotome
• Catalog Number: 020301
• Company Name: MEDGYN PRODUCTS, INC.
• Labeler DUNS: 103913430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-30
• Public Version: 1
• Public Version Date: 2024-05-08
• Public Version Status: New
• Public Device Record Key: 79e010ea-28e4-4eb6-8d80-def739caf821

Device Description

MedGyn Disposable Amnio Hook

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
HGE	Amniotome	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35472	Amniotome, single-use	A surgical instrument used to cut/rupture the amniotic membrane (i.e., the amnion - the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid) to assist in childbirth, without causing injury to the mother or foetus. It is long and shaft-like, and terminates in a sharp hook or protected blade used to rupture the membrane. It is typically made of disposable plastic materials, and may be curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotic perforator or forceps and/or a trocar. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M803020301	HIBCC