FDA UDI
In Commercial Distribution
🇺🇸 United States
LS-5™ ePTFE QUICK LOAD®
DI: 00850200006421
·
Model: 022295
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LS-5™ ePTFE QUICK LOAD®
- Primary DI
- 00850200006421
- Version / Model
- 022295
- Catalog Number
- 022295
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-13
- Public Version
- 5
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 24cbe72d-4b5b-42f9-b0b3-cc41d1e4a470
Device Description
LS-5™ ePTFE QUICK LOAD® SUTURE, MONOFILAMENT, NON-ABSORBABLE, 38", 2 FERRULES
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBY | SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE | General, Plastic Surgery | 878.5035 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62710 | Chordae tendinae prosthesis | An implantable cord intended to be used as an artificial substitute for the chordae tendinae (heart strings) to restore natural function to a defective (regurgitant, prolapsed) mitral valve. The implantable cord is typically delivered via transapical or transfemoral access. It is a suture-like string made of synthetic polymer materials [e.g., expanded polytetrafluoroethylene (ePTFE) fabric], and is attached between the valve leaflet and either the epicardium or myocardium with a dedicated, disposable, manually-operated delivery tool (included); additional devices used to facilitate implantation may be included with the implant. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850200006428 | GS1 | Inner pack | 12 | In Commercial Distribution | |
| Primary | 00850200006421 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163639 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 38 | Inch |