AbGrab

Basic Information

• Brand Name: AbGrab
• Primary DI: 10860003326418
• Version / Model: AG1-001
• Company Name: Lapovations, LLC
• Labeler DUNS: 081051875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-08-19
• Public Version: 1
• Public Version Date: 2021-08-27
• Public Version Status: New
• Public Device Record Key: 8b5e96d7-bc4b-4942-99a7-c264e1bfdaf1

Device Description

AbGrab Laparoscopic Lifting Device

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: 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
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	884.1720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61851	Laparoscopic access suction dome	A sterile dome-shaped device intended to facilitate laparoscopic-insufflation needle insertion by causing the anterior abdominal wall to separate from the underlying viscera using vacuum applied to the surface of the abdomen, thereby creating a space for the needle tip. It is typically made of synthetic polymer materials and is designed to be used with the hospital central vacuum system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860003326418	GS1
Unit of Use	00860003326411	GS1