Sonicision
GUDID 20884521592909
Reusable Battery Insertion Guide
Covidien LP
Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide Surgical instrument battery insertion guide| Primary Device ID | 20884521592909 |
| NIH Device Record Key | 8395103d-ea97-4d3e-856d-72d68f815886 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonicision |
| Version Model Number | SCBIGA |
| 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 | false |
| Lot Batch | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521592902 [Primary] |
| GS1 | 20884521592909 [Package] Contains: 10884521592902 Package: PACK_OR_INNER_PACK [2 Units] In Commercial Distribution |
| GS1 | 30884521592906 [Package] Package: CASE [16 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180149
FDA Product Code
| LFL | Instrument, ultrasonic surgical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
[20884521592909]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-05-26 |
| Device Publish Date | 2018-08-22 |
On-Brand Devices [Sonicision]
| 10884521052666 | Cordless Ultrasonic Dissector |
| 10884521128927 | Sterilization Tray |
| 10884521592865 | Reusable Generator |
| 10884521592919 | Reusable Sterilization Tray |
| 10884521592896 | Reusable Battery Charger |
| 10884521592889 | Reusable Battery Pack |
| 20884521807904 | Cordless Ultrasonic Dissector |
| 20884521807898 | Cordless Ultrasonic Dissector |
| 20884521807881 | Cordless Ultrasonic Dissector |
| 20884521807874 | Cordless Ultrasonic Dissector |
| 10884521133624 | Reusable Battery Pack |
| 10884521052659 | Cordless Ultrasonic Dissector |
| 10884521036536 | Reusable Generator |
| 20884521592855 | Curved Jaw Cordless Ultrasonic Dissector |
| 20884521592848 | Curved Jaw Cordless Ultrasonic Dissector |
| 20884521592831 | Curved Jaw Cordless Ultrasonic Dissector |
| 20884521592824 | Curved Jaw Cordless Ultrasonic Dissector |
| 20884521592909 | Reusable Battery Insertion Guide |
| 20884524002955 | Torque Wrench |
| 20884521195223 | Cordless Ultrasonic Dissector |
| 20884521195216 | Cordless Ultrasonic Dissector |
| 20884521195209 | Cordless Ultrasonic Dissector |
| 10884521807860 | Cordless Ultrasonic Dissector |
Trademark Results [Sonicision]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONICISION 85057162 4195108 Live/Registered |
COVIDIEN LP 2010-06-08 |
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