SEW-EASY® 022050
GUDID 10850200006541
SEW-EASY® M DEVICE
LSI Solutions, Inc.
Suturing unit, single-use| Primary Device ID | 10850200006541 |
| NIH Device Record Key | a0e5374d-3799-4c4e-baa0-28fd8095a5ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEW-EASY® |
| Version Model Number | 022050 |
| Catalog Number | 022050 |
| 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 | false |
| 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
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
| Length | 3.175 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006544 [Primary] |
| GS1 | 10850200006541 [Package] Contains: 00850200006544 Package: Case [6 Units] In Commercial Distribution |
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 |
| 10850200006527 | SEW-EASY® DEVICE KIT, 3.5mm |
| 10850200006510 | SEW-EASY® DEVICE KIT, 5mm |
| 10850200006503 | SEW-EASY® COMBO KIT, 3.5mm |
| 10850200006497 | SEW-EASY® COMBO KIT, 5mm |
Trademark Results [SEW-EASY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEW-EASY 86765295 5167376 Live/Registered |
LSI SOLUTIONS, INC. 2015-09-23 |
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