DEVICE: Lariat RS (10840143901713)

Device Identifier (DI) Information

Lariat RS
30-06
In Commercial Distribution
FG-0028
ATRICURE, INC.
10840143901713
GS1

1
006133784 *Terms of Use
00818354017557
Suture Delivery Device
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Device Characteristics

Labeling does not contain MRI Safety Information
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
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FDA Product Code

[?]
Product Code Product Code Name
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
HCF Instrument, Ligature Passing And Knot Tying
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153096 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

fe0a4faa-10dd-4dd1-8ac6-3155598bc1e6
January 19, 2021
1
January 11, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30840143901724 1 10840143901713 In Commercial Distribution box
50840143901711 10 30840143901724 In Commercial Distribution case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
650 354 1200
info@sentreheart.com
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