Edge E2350HDB
GUDID 30884524000637
Rocker Switch Pencil,Blade Electrode, Holster
Covidien LP
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use| Primary Device ID | 30884524000637 |
| NIH Device Record Key | f46b1f01-f653-4b9a-a408-86d7046eddb0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Edge |
| Version Model Number | E2350HDB |
| Catalog Number | E2350HDB |
| 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 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
| Length | 15 Feet |
Operating and Storage Conditions
| 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 |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884524000633 [Primary] |
| GS1 | 30884524000637 [Package] Contains: 10884524000633 Package: CASE [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K813071
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 | 2019-04-23 |
| Device Publish Date | 2016-09-24 |
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 |
Trademark Results [Edge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EDGE 98759433 not registered Live/Pending |
National Nail Corp. 2024-09-19 |
 EDGE 98729594 not registered Live/Pending |
Luxo International Inc 2024-09-03 |
 EDGE 98623660 not registered Live/Pending |
Edge Medical Lounge 2024-06-28 |
 EDGE 98622837 not registered Live/Pending |
Feon Energy, Inc. 2024-06-27 |
 EDGE 98594419 not registered Live/Pending |
Edge Medical Lounge 2024-06-11 |
 EDGE 98579267 not registered Live/Pending |
Edge Animal Health, Inc. 2024-05-31 |
 EDGE 98579255 not registered Live/Pending |
Edge Animal Health, Inc. 2024-05-31 |
 EDGE 98568410 not registered Live/Pending |
Jacobs Corporation 2024-05-24 |
 EDGE 98568389 not registered Live/Pending |
Jacobs Corporation 2024-05-24 |
 EDGE 98562577 not registered Live/Pending |
Straight Edge Labs, LLC 2024-05-21 |
 EDGE 98524782 not registered Live/Pending |
Xiaojiao, Zhao 2024-04-29 |
 EDGE 98383811 not registered Live/Pending |
Edge Restoration, LLC 2024-01-31 |
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