Paradigm EDGE

Basic Information

• Brand Name: Paradigm EDGE
• Primary DI: 20653405988332
• Version / Model: AES-50SP
• Catalog Number: AES-50SP
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-30
• Public Version: 1
• Public Version Date: 2023-04-07
• Public Version Status: New
• Public Device Record Key: e17d08e1-51d0-4597-8cdf-da60bdb1d018

Device Description

Paradigm EDGE Hip Probe, 50 Degree

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: 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
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57944	Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20653405988332	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 cm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -22 – 104 Degrees Fahrenheit