AED

Basic Information

• Brand Name: AED
• Primary DI: 00848657021272
• Version / Model: AED27175A
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Labeler DUNS: 839138955
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-30
• Public Version: 5
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: aa10acc3-b12c-4e68-9b08-1bc9c3592ac8
• Distribution End Date: 2018-12-13

Device Description

Storz (style) Flexible Grasper

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIH	HYSTEROSCOPE (AND ACCESSORIES)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35524	Flexible endoscopic tissue manipulation forceps, reusable	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848657021272	GS1

Premarket Submissions

Submission Number	Supplement Number
K141515	000