DEVICE: TearSaver® - 0.6 mm (13700773734785)

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Device Record History
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Device Identifier (DI) Information
TearSaver® - 0.6 mm
S2.3862
In Commercial Distribution

FCI S A S FCI 20 22
13700773734785
GS1

2
763408366 *Terms of Use
Punctum plug
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Device Characteristics
MR Safe
No
No
Yes
No
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?
36237 Lacrimal punctum plug
A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LZU Plug, Punctum
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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
f0be9434-0c59-4fc4-bdf4-0a3a62d05d0a
November 21, 2023
1
November 13, 2023
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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: 23700773734782 CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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