DEVICE: RAPORT™ (00850012846345)

Device Identifier (DI) Information

RAPORT™
081510
In Commercial Distribution
081510
LSI Solutions, Inc.
00850012846345
GS1

1
603420183 *Terms of Use
RAPORT™ KIT
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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?
63420 Suture/ligature tightener, single-use
A hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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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
Length: 50 Millimeter
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Device Record Status

fd1881f2-09c0-4ccb-b0b9-ad0c133f1577
May 30, 2024
1
May 22, 2024
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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
10850012846342 6 00850012846345 In Commercial Distribution Inner Pack
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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
Yes
No CLOSE

Customer Contact

[?]
+1(866)575-3493
regulatorydpt@lsisolutions.com
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