Roticulator
GUDID 20884521047706
Articulating Stapler
Covidien LP
Open-surgery manual linear cutting stapler, single-use| Primary Device ID | 20884521047706 |
| NIH Device Record Key | 0cf52046-1e29-44cd-bb44-f8d592c3f286 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Roticulator |
| Version Model Number | 017614 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Device Dimensions
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
| Length | 55 Millimeter |
| Height | 4.8 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521047709 [Primary] |
| GS1 | 20884521047706 [Package] Contains: 10884521047709 Package: CASE [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K855047
FDA Product Code
| GDW | STAPLE, IMPLANTABLE |
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 | 2024-05-31 |
| Device Publish Date | 2015-08-28 |
On-Brand Devices [Roticulator]
| 20884521047737 | Articulating Stapler |
| 20884521047720 | Articulating Stapler |
| 20884521047713 | Articulating Stapler |
| 20884521047706 | Articulating Stapler |
| 20884521047690 | Articulating Stapler |
Trademark Results [Roticulator]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROTICULATOR 73675012 1479504 Live/Registered |
UNITED STATES SURGICAL CORPORATION 1987-07-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.