AED 22FR Bipolar Electrode Cutting Loop 32-4240BP

GUDID 00848657074902

An 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.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Primary Device ID00848657074902
NIH Device Record Key8da1ee01-7bb6-4706-acb7-df961bda05b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAED 22FR Bipolar Electrode Cutting Loop
Version Model Number32-4240BP
Catalog Number32-4240BP
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
GS100848657074902 [Primary]

FDA Product Code

FASElectrode, Electrosurgical, Active, Urological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

Moist Heat or Steam Sterilization


[00848657074902]

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.

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00848657068796 - Retractor2023-10-20 A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision t
00848657069700 - Instrument Ligature Passing and Knot Tying2023-10-20 Instrument Ligature Passing and Knot Tying
00848657070218 - Laryngostroboscope2023-10-20 Laryngostroboscopes employ the oscillating light of a high-power fluorescent light source that is monitored by the laryngeal vib
00848657071017 - Light, Headband, Surgical2023-10-20 Light, Headband, Surgical
00848657075749 - 5 Fr Fiber Guide 2023-10-20

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