Auto Suture
GUDID 20884521081083
Structural Balloon Trocar
Covidien LP
Surgical balloon dissector| Primary Device ID | 20884521081083 |
| NIH Device Record Key | cb7acc66-bac2-44fc-acb3-0382e8ecb6ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auto Suture |
| Version Model Number | OMS-T10SB |
| 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 |
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 |
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 |
| 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 | 10884521081086 [Primary] |
| GS1 | 20884521081083 [Package] Contains: 10884521081086 Package: CASE [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K924011
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
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 | 2022-10-11 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Auto Suture]
| 10884521539648 | Blunt Tip Trocar |
| 20884521066394 | Anti-Fog Kit |
| 20884521184463 | CoPilot System |
| 20884521170282 | Gamma Probe Drape,For Use with Navigator GPS System |
| 20884521080840 | Threaded Trocar |
| 20884521080758 | Premium Extractor |
| 20884521081090 | Blunt Tip Trocar |
| 20884521081083 | Structural Balloon Trocar |
| 20884521081076 | Blunt Tip Trocar |
| 20884521080864 | Threaded Trocar |
| 20884521552446 | Blunt Tip Trocar |
| 20884521545134 | Locking Trocar |
| 20884521527383 | Blunt Tip Trocar |
| 20884521080871 | Blunt Tip Trocar |
| 20884521080833 | Flexible Trocar |
Trademark Results [Auto Suture]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUTO SUTURE 73078907 1065230 Live/Registered |
UNITED STATES SURGICAL CORPORATION 1976-03-02 |
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