FDA UDI
In Commercial Distribution
🇺🇸 United States
Lariat RS
DI: 10840143901713
·
Model: 30-06
·
ATRICURE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Lariat RS
- Primary DI
- 10840143901713
- Version / Model
- 30-06
- Catalog Number
- FG-0028
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-11
- Public Version
- 1
- Public Version Date
- 2021-01-19
- Public Version Status
- New
- Public Device Record Key
- fe0a4faa-10dd-4dd1-8ac6-3155598bc1e6
Device Description
Suture Delivery Device
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45717 | Suture knot pusher, single-use | A hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840143901724 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 10840143901713 | GS1 | ||||
| Package | 50840143901711 | GS1 | case | 10 | In Commercial Distribution | |
| Previous | 00818354017557 | GS1 |
Customer Contacts
- Phone
- 650 354 1200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153096 | 000 |