CleanCoat
GUDID 20884521550763
Laproscopic Straight Spatula Electrode
Covidien LP
Endoscopic electrosurgical electrode, monopolar, single-use| Primary Device ID | 20884521550763 |
| NIH Device Record Key | ddadadea-ca6e-4ce1-a5aa-2f1b5f90104c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CleanCoat |
| Version Model Number | E3770-36C |
| 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 | 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 | |
| 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 | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521550766 [Primary] |
| GS1 | 20884521550763 [Package] Contains: 10884521550766 Package: PACK_OR_INNER_PACK [10 Units] In Commercial Distribution |
| GS1 | 30884521550760 [Package] Package: CASE [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153265
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 | 5 |
| Public Version Date | 2022-05-25 |
| Device Publish Date | 2017-06-28 |
On-Brand Devices [CleanCoat]
| 20884521550824 | Laparoscopic Wire L-Hook Electrode Coated |
| 20884521550800 | Laparoscopic Wire L-Hook Electrode Coated |
| 20884521550831 | Laparoscopic Wire L-Hook Electrode Coated |
| 20884521550817 | Laparoscopic Wire L-Hook Electrode Coated |
| 20884521550794 | Laparoscopic Wire J-Hook Electrode Coated |
| 20884521550787 | Laproscopic Curved Spatula Electrode |
| 20884521550770 | Laproscopic Curved Spatula Electrode |
| 20884521550763 | Laproscopic Straight Spatula Electrode |
Trademark Results [CleanCoat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEANCOAT 88194006 not registered Live/Pending |
Applied Materials, Inc. 2018-11-14 |
 CLEANCOAT 87549902 5740491 Live/Registered |
National Automotive Parts Association 2017-07-31 |
 CLEANCOAT 86598331 5050656 Live/Registered |
Covidien LP 2015-04-15 |
 CLEANCOAT 85038666 not registered Dead/Abandoned |
Safety Innovation, LLC 2010-05-14 |
 CLEANCOAT 78252566 2928282 Dead/Cancelled |
9119-5768 Quebec Inc. 2003-05-21 |
 CLEANCOAT 78250515 not registered Dead/Abandoned |
Kohler France SAS 2003-05-15 |
 CLEANCOAT 77303284 3448778 Dead/Cancelled |
Pacific Market International, LLC 2007-10-12 |
 CLEANCOAT 77229019 3559609 Live/Registered |
Kohler Co. 2007-07-13 |
 CLEANCOAT 76659317 not registered Dead/Abandoned |
PACIFIC MARKET INTERNATIONAL, LLC 2006-05-01 |
 CLEANCOAT 76216881 not registered Dead/Abandoned |
Applied Materials, Inc. 2001-02-21 |
 CLEANCOAT 75584879 not registered Dead/Abandoned |
J.M. Huber Corporation 1998-11-05 |
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