DEVICE: SofTIP (10840143901812)

Device Identifier (DI) Information

SofTIP
60-02
In Commercial Distribution
FG-0008
ATRICURE, INC.
10840143901812
GS1

1
006133784 *Terms of Use
00818354017601
SofTIP Guide Cannula
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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?
63487 Suture cutter, single-use
A hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. 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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090385 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

c154e4bc-2669-415b-81d0-a4cd6d01eb03
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
30840143901809 1 10840143901812 In Commercial Distribution box
50840143901780 10 30840143901809 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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