DEVICE: Lariat RS (10840143909443)
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Device Identifier (DI) Information
Lariat RS
30-06
In Commercial Distribution
FG-0028-02
ATRICURE, INC.
30-06
In Commercial Distribution
FG-0028-02
ATRICURE, INC.
LARIAT RS Suture Delivery Device, 45mm
Device Characteristics
| MR Safe | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HCF | Instrument, Ligature Passing And Knot Tying |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K153096 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store in a cool, dry place |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 45 Millimeter |
Device Record Status
f205d678-cdb9-4076-b2eb-79316a78f123
April 14, 2023
1
April 06, 2023
April 14, 2023
1
April 06, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 30840143909447 | 1 | 10840143909443 | In Commercial Distribution | Box | |
| 50840143909441 | 10 | 30840143909447 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-449-2342
SEhlert@atricure.com
SEhlert@atricure.com