Amnicot

Basic Information

• Brand Name: Amnicot
• Primary DI: 09350902000211
• Version / Model: Amnicot German
• Catalog Number: ACD01-G
• Company Name: GO MEDICAL INDUSTRIES PTY. LTD.
• Labeler DUNS: 757634266
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ca8966d2-86f8-4b86-ac6e-e9d71d6ea208

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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
HGE	Amniotome	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46520	Amniotic membrane perforator, single-use	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 made of 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	9350902000242	GS1	Outer carton	5200	In Commercial Distribution
Primary	09350902000211	GS1
Package	9350902000235	GS1	Second inner carton	2600	In Commercial Distribution
Package	09350902000228	GS1	Inner carton	100	Not in Commercial Distribution	2018-07-01

Premarket Submissions

Submission Number	Supplement Number
K850758	000