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 Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis Chordae tendinae prosthesis 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.
| 10850012846281 - VIRTUOSEW™ | 2024-02-22 VIRTUOSEW™ DEVICE |
| 10850012846298 - AVR NAVIGATOR™ | 2024-02-12 AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE |
| 10850012846304 - AVR NAVIGATOR™ | 2024-02-12 AVR NAVIGATOR™ MEDIUM RETRACTOR WITH DELIVERY DEVICE |
| 10850012846311 - AVR NAVIGATOR™ | 2024-02-12 AVR NAVIGATOR™ LARGE RETRACTOR WITH DELIVERY DEVICE |
| 00850012846321 - miniARM® multiSTATION™ System | 2024-01-11 BITA RetroSterno™ Paddle |
| 10850012846267 - AnastoPod™ | 2023-07-31 AnastoPod™ DEVICE |
| 10850012846007 - PNEUMOSTOP® | 2022-11-14 PNEUMOSTOP® DEVICE |
| 10850012846014 - PNEUMOSTOP® | 2022-11-14 PNEUMOSTOP® PLUS DEVICE |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.