GelPOINT V-Path

Basic Information

• Brand Name: GelPOINT V-Path
• Primary DI: 00607915138486
• Version / Model: C2A11
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 1
• Public Version Date: 2019-09-25
• Public Version Status: New
• Public Device Record Key: 0d43c63c-551b-4f20-ad81-dd6cc73fdd7c

Device Description

Transvaginal Access Platform

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
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	884.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47432	Radial surgical retractor seal cap	A sterile device intended to be used with a radial surgical retractor to provide an adjustable membrane that functions as an iris valve seal and access port. It is secured to the retaining latches of the external ring of the inserted retractor whereby the operator can open/close the port by turning the upper seal ring (the action revolves the thin membrane similar to the iris shutter of a camera). It is used to facilitate surgical access while helping to maintain pneumoperitoneum during colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10607915138483	GS1		1	In Commercial Distribution
Primary	00607915138486	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			11 cm