Edge E1455B

GUDID 10884521038394

Insulated Blade Electrode,Safety Sleeve

Covidien LP

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10884521038394
• NIH Device Record Key: be519046-c307-49b5-b508-292080b18efb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge
• Version Model Number: E1455B
• Catalog Number: E1455B
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
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• Phone: +1(508)261-8000
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• Phone: +1(508)261-8000
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• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521038394 [Package]; Contains: 20884521038391; Package: CASE [8 Units]; In Commercial Distribution
GS1	10884521713208 [Primary]
GS1	20884521038391 [Package]; Contains: 10884521713208; Package: PACK_OR_INNER_PACK [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955836

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-22
• Device Publish Date: 2016-11-18

On-Brand Devices [Edge]

• 30884524002129: Blade Electrode
• 10884521175464: Blade Electrode
• 10884521036949: Blade Electrode
• 10884521175518: Needle Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521175471: Blade Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521175426: Hex-locking Blade Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521038509: Insulated Needle Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521037250: Insulated Blade Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521037137: Insulated Blade Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521037120: Blade Electrode;Caution: For manufacturing, processing, or repacking.
• 10884524002255: Button Switch Pencil,Blade Electrode, Holster
• 10884524002248: Button Switch Pencil,Blade Electrode, Holster
• 10884524002231: Button Switch Pencil,Blade Electrode, Holster
• 10884524002224: Rocker Switch Pencil,Blade Electrode, Holster
• 10884524002217: Rocker Switch Pencil,Blade Electrode, Holster
• 10884524002200: Rocker Switch Pencil,Blade Electrode, Holster
• 10884524001524: Button Switch Pencil,Blade Electrode, Holster, Smoke Attachment
• 20884524001484: Button Switch Pencil,Blade Electrode, Holster, Smoke Attachment
• 20884524001477: Rocker Switch Pencil,Blade Electrode, Holster, Smoke Attachment
• 30884524000637: Rocker Switch Pencil,Blade Electrode, Holster
• 30884524000620: Rocker Switch Pencil,Blade Electrode, Holster
• 30884524000026: Button Switch Pencil,Blade Electrode, Holster
• 10884521713147: Blade Electrode
• 10884521713130: Blade Electrode
• 10884521713123: Blade Electrode
• 10884521038394: Insulated Blade Electrode,Safety Sleeve
• 20884521803661: Edge Insulated Blade Electrode 2.5"
• 10884521038523: Insulated Needle Electrode Safety Sleeve(TM)
• 10884521038479: Insulated Blade Electrode Safety Sleeve(TM);Caution: For manufacturing,processing, or repacking.
• 10884521038554: Hex-locking Blade Electrode;Caution: For manufacturing, processing, or repacking.
• 20884521539775: Bronchoscope Adapter;For use with Olympus 190 bronchoscopes
• 20884521539768: Bronchoscope Adapter;For use with Fujinon bronchoscopes
• 20884521539751: Bronchoscope Adapter;For use with Pentax bronchoscopes
• 20884521539744: Bronchoscope Adapter;For use with Olympus bronchoscopes
• 10884521199545: Bronchoscope Adapter;For use with Olympus 190 bronchoscopes
• 10884521199538: Bronchoscope Adapter;For use with Fujinon bronchoscopes
• 10884521199521: Bronchoscope Adapter;For use with Pentax bronchoscopes
• 10884521199507: Bronchoscope Adapter;For use with Olympus bronchoscopes
• 30884524000613: Pencil,Blade Electrode, Holster
• 10884521037021: Needle Electrode
• 10884521175648: Needle Electrode;Caution: For manufacturing, processing, or repacking.
• 10884521175549: Insulated Needle Electrode
• 10884521581425: Firm Tip;Extended Working Channel;190 Catheter
• 10884521581418: Firm Tip;Extended Working Channel;Straight Catheter
• 10884521581401: Firm Tip;Extended Working Channel;Medial Catheter
• 10884521581395: Firm Tip; Endobronchial Procedure Kit;Medial Catheter
• 10884521581388: Firm Tip; Endobronchial Procedure Kit;190 Catheter
• 10884521545571: Firm Tip;Endobronchial Procedure Kit;90 Catheter
• 10884521545564: Firm Tip; Endobronchial Procedure Kit;45 Catheter
• 10884521545557: Firm Tip;Endobronchial Procedure Kit;180 Catheter