LS-5™ ePTFE QUICK LOAD® 022295
GUDID 10850200006428
LS-5™ ePTFE QUICK LOAD® SUTURE, Monofilament, Non-Absorbable, 38”, 2 Ferrules
LSI Solutions, Inc.
Chordae tendinae prosthesis| Primary Device ID | 10850200006428 |
| NIH Device Record Key | 24cbe72d-4b5b-42f9-b0b3-cc41d1e4a470 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LS-5™ ePTFE QUICK LOAD® |
| Version Model Number | 022295 |
| Catalog Number | 022295 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
| Length | 38 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006421 [Primary] |
| GS1 | 10850200006428 [Package] Contains: 00850200006421 Package: Box [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163639
FDA Product Code
| NBY | SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE |
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 |
Devices Manufactured by LSI Solutions, Inc.
| 00850012846376 - multiSTATION™ | 2024-11-25 10mm COUPLER |
| 10850200006497 - SEW-EASY® | 2024-10-29 SEW-EASY® COMBO KIT, 5mm |
| 10850200006503 - SEW-EASY® | 2024-10-29 SEW-EASY® COMBO KIT, 3.5mm |
| 10850200006510 - SEW-EASY® | 2024-10-29 SEW-EASY® DEVICE KIT, 5mm |
| 10850200006527 - SEW-EASY® | 2024-10-29 SEW-EASY® DEVICE KIT, 3.5mm |
| 00850012846253 - multiSTATION™ | 2024-10-07 DOC-X 15™ EXTENDER |
| 00850012846352 - multiSTATION™ | 2024-10-07 DOC-X 25™ EXTENDER |
| 00850012846369 - multiSTATION™ | 2024-10-07 DOC-X 45™ EXTENDER |
Trademark Results [LS-5]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LS-5 90661747 not registered Live/Pending |
LSI Solutions, Inc. 2021-04-21 |
 LS-5 86957803 not registered Live/Pending |
LSI Solutions, Inc. 2016-03-30 |
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