LigaSure Impact
GUDID 20884521612522
Curved, Large Jaw, Open Sealer/Divider Nano-coated
Covidien LP
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use| Primary Device ID | 20884521612522 |
| NIH Device Record Key | 85eb847d-43ba-4120-a36e-9999983daab2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LigaSure Impact |
| Version Model Number | LF4418 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| 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 |
Device Dimensions
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
| Length | 18 Centimeter |
| Outer Diameter | 36 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521612525 [Primary] |
| GS1 | 20884521612522 [Package] Contains: 10884521612525 Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162047
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 | 8 |
| Public Version Date | 2022-04-05 |
| Device Publish Date | 2017-05-29 |
On-Brand Devices [LigaSure Impact]
| 20884521171890 | Tissue Fusion Open Instrument |
| 20884521165318 | Curved, Large Jaw, Open Sealer/Divider |
| 20884521103358 | Tissue Fusion Open Instrument |
| 20884521612522 | Curved, Large Jaw, Open Sealer/Divider Nano-coated |
Trademark Results [LigaSure Impact]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIGASURE IMPACT 78705338 3687532 Live/Registered |
Covidien AG 2005-09-01 |
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