AED 27770E Monopolar Coagulating Ball Electrode, 8FR x 45cm AED27770E

GUDID 00848657069311

An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device ID00848657069311
NIH Device Record Keyc59db1cf-b29f-4823-9a1d-16a254568270
Commercial Distribution StatusIn Commercial Distribution
Brand NameAED 27770E Monopolar Coagulating Ball Electrode, 8FR x 45cm
Version Model NumberAED27770E
Catalog NumberAED27770E
Company DUNS839138955
Company NameNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md
Phone+8182272720
Emailcustomerservice@aed.md

Device Identifiers

Device Issuing AgencyDevice ID
GS100848657069311 [Primary]

FDA Product Code

FASElectrode, Electrosurgical, Active, Urological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


[00848657069311]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-17
Device Publish Date2023-10-09

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

00848657076975 - AED2024-07-30 AED Titanium Pistol Handle Needle Holder, 38cm, Straight Jaw; Non-Magnetic Version
00848657076982 - AED2024-07-30 Non-Magnetic Johan Bowel Grasper 5mm x 36cm
00848657076999 - AED2024-07-30 Non-Magnetic Maryland Grasper 5mm x 36cm, Serrated
00848657077002 - AED2024-07-30 Non-Magnetic Metzenbaum 5mm x 36cm, Curved
00848657077019 - AED2024-07-30 Precise Lap Bulldog Clamp with diamond dust anti-skid coating, 60mm, Non-Magnetic Version
00848657077026 - AED2024-07-30 Precise Lap Bulldog Clamp Forcep, 12.5mm x 38cm, Non-Magnetic Version
00848657076968 - ENDOPRO-CAM Master Series2024-07-23 Endoscopic Video System
00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.