Mabis DMI

Basic Information

• Brand Name: Mabis DMI
• Primary DI: 10767056096018
• Version / Model: D 9601
• Company Name: D-M-S HOLDINGS, INC.
• Labeler DUNS: 062028220
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-19
• Public Version: 2
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 5bcc79fd-039e-485f-84e1-aac37f13eb9c
• Distribution End Date: 2023-05-05

Device Description

AMNIHOOK AMNIOTIC MEMBRANE PERFORATOR

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
HGE	Amniotome	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12990	Amniotic membrane perforator, reusable	A surgical instrument used to 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 typically long and shaft-like, and terminates in a rounded nose with a sharp hook. It is typically made of high-grade stainless steel or durable plastic materials, and may be straight or curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotome or forceps and/or a trocar. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10767056096018	GS1