DEVICE: SureCUT (10840143901799)

Device Identifier (DI) Information

SureCUT
50-01
In Commercial Distribution
FG-0006
ATRICURE, INC.
10840143901799
GS1

1
006133784 *Terms of Use
00818354017595
SureCUT Suture Cutter
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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?
64565 Pericardioscopic access cannula
A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest and through the pericardial cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive cardiac procedure (e.g., epicardial ablation). It is intended for subxiphoid or transdiaphragmatic access, and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade intended to assist introduction. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZT Cutter, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

420dd398-83e6-4efd-973a-b476cbde129d
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
30840143901786 1 10840143901799 In Commercial Distribution box
50840143901766 10 30840143901786 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

[?]
No Customer Contact currently defined
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