DURAKNOT SW100
GUDID 30705036002882
Endosuture System Suture Assistant
ETHICON ENDO-SURGERY, LLC
Endoscopic suturing unit, single-use| Primary Device ID | 30705036002882 |
| NIH Device Record Key | 7267e7fa-72ad-4acf-8fee-497cb278d219 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DURAKNOT |
| Version Model Number | SW100 |
| Catalog Number | SW100 |
| Company DUNS | 044606982 |
| Company Name | ETHICON ENDO-SURGERY, LLC |
| Device Count | 4 |
| 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705036002888 [Unit of Use] |
| GS1 | 20705036002885 [Primary] |
| GS1 | 30705036002882 [Package] Contains: 20705036002885 Package: CASE [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972679
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-15 |
Devices Manufactured by ETHICON ENDO-SURGERY, LLC
| 20705036027857 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter Reload 100mm BLUE |
| 30705036027861 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter Reload 100mm GREEN |
| 20705036027871 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter Reload 60mm BLUE |
| 40705036027882 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter Reload 60mm GREEN |
| 30705036027892 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter Reload 80mm BLUE |
| 30705036027908 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter Reload 80mm GREEN |
| 30705036030878 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter 60mm |
| 30705036030885 - Echelon Linear Cutter | 2024-04-23 Echelon Linear Cutter 80mm |
Trademark Results [DURAKNOT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURAKNOT 75635973 2453760 Live/Registered |
JOHNSON & JOHNSON 1999-02-08 |
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