Endo Stitch
GUDID 20884521100005
Suturing Device
Covidien LP
Suturing unit, single-use| Primary Device ID | 20884521100005 |
| NIH Device Record Key | 2078e66e-983d-40e8-a900-a485f57f9c33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo Stitch |
| Version Model Number | 173016 |
| 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 | 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 | |
| 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
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521100008 [Primary] |
| GS1 | 20884521100005 [Package] Contains: 10884521100008 Package: CASE [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K934738
FDA Product Code
| OCW | Endoscopic tissue approximation device |
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 | 2021-05-25 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Endo Stitch]
| 20884521100012 | Suturing Device |
| 20884521100005 | Suturing Device |
Trademark Results [Endo Stitch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDO STITCH 74347852 1914149 Live/Registered |
COVIDIEN LP 1993-01-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.