DEVICE: TLS (37613252083574)

Device Identifier (DI) Information

TLS
6660
In Commercial Distribution
6660
Stryker Leibinger GmbH & Co. KG
37613252083574
GS1

6
316153956 *Terms of Use
4mm Flat Drain with Side Holes, Sterile
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35824 Closed-wound drainage kit
A collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GCY APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K833586 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

3d13343b-4a67-45f7-a1ac-264f6f6099f4
February 05, 2021
4
August 24, 2016
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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
No Package DIs found
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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: 07613252083573 CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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