SEW-EASY® 022804
GUDID 10850200006640
SEW-EASY® DEVICE 5.0 KIT
LSI Solutions, Inc.
Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use| Primary Device ID | 10850200006640 |
| NIH Device Record Key | 0615be21-60cc-4b58-822d-65bf68d62e15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEW-EASY® |
| Version Model Number | 022804 |
| Catalog Number | 022804 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 Dimensions
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Width | 5 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006643 [Primary] |
| GS1 | 10850200006640 [Package] Contains: 00850200006643 Package: Case [6 Units] In Commercial Distribution |
| GS1 | 40850200006641 [Unit of Use] |
FDA Product Code
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2020-03-13 |
On-Brand Devices [SEW-EASY®]
| 10850200006886 | SEW-EASY® SNARE |
| 10850200006640 | SEW-EASY® DEVICE 5.0 KIT |
| 10850200006633 | SEW-EASY® DEVICE 5.0 COMBO KIT |
| 10850200006541 | SEW-EASY® M DEVICE |
Trademark Results [SEW-EASY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEW-EASY 86765295 5167376 Live/Registered |
LSI SOLUTIONS, INC. 2015-09-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.