MaxTack
GUDID 20884521826264
Motorized Fixation Device 30 Absorbable Tacks
Covidien LP
Soft-tissue repair material fixation tack| Primary Device ID | 20884521826264 |
| NIH Device Record Key | d2322aed-dd3d-4044-bbbf-54d05ea25275 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MaxTack |
| Version Model Number | MAXTACK30 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 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 | |
| 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 | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 118 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521826267 [Primary] |
| GS1 | 20884521826264 [Package] Contains: 10884521826267 Package: PACK_OR_INNER_PACK [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231240
FDA Product Code
| OCW | Endoscopic tissue approximation device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-17 |
| Device Publish Date | 2024-09-09 |
Devices Manufactured by Covidien LP
| 20884521703732 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703756 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703770 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521822891 - DAR | 2024-12-09 Closed Suction System, Replaceable Catheter Endotracheal Length |
| 10884521845480 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER STND LENGTH FT |
| 10884521845497 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER XL LENGTH FT |
| 20884521581859 - Barrx | 2024-11-18 RFA Cleaning Cap Small |
| 20884521581866 - Barrx | 2024-11-18 RFA Cleaning Cap Medium |
Trademark Results [MaxTack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAXTACK 98072803 not registered Live/Pending |
Covidien LP 2023-07-06 |
 MAXTACK 97908082 not registered Live/Pending |
MAX ROOFING PRODUCTS, LLC 2023-04-26 |
 MAXTACK 90152172 not registered Live/Pending |
Covidien LP 2020-09-01 |
 MAXTACK 87311830 not registered Dead/Abandoned |
Lanuza, Craig S. 2017-01-24 |
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