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.
| 00850012846482 - multiSTATION™ | 2025-09-08 TriFLEX™ |
| 10850012846533 - BOBsnare Device | 2025-08-29 BOBsnare Device |
| 10850012846540 - RAM® COR-SUTURE® QUICK LOAD® | 2025-08-05 RAM® COR-SUTURE® QUICK LOAD® 6-TRAY 5MM NON-PLGT 2-0 POLYESTER, (3) GREEN and (3) WHITE |
| 10850012846434 - PicoDriver | 2025-07-28 PicoDriver Device |
| 10850012846465 - RAPORT™ KIT | 2025-07-17 RAPORT™ KIT RP-75™ |
| 10850012846472 - RAPORT™ KIT | 2025-07-17 RAPORT™ KIT RP-100™ |
| 10850012846526 - RD® QUICK LOAD® | 2025-07-17 RD® QUICK LOAD® SUTURE, 2-0 MONOGLIDE® DUO |
| 10850012846458 - JNW URTRAC | 2025-06-16 JNW URTRAC INSTRUMENT GUIDE |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.