DEVICE: SUMMIT MEDICAL (00810061911258)

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Device Record History
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Device Identifier (DI) Information
SUMMIT MEDICAL
3002
In Commercial Distribution
3002
KRISHNA IMPORTS INC
00810061911258
GS1

2
081853285 *Terms of Use
ACCUFLO, STERILE, LARGE
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Device Characteristics
Labeling does not contain MRI Safety Information
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 [?]
K140352 000
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.89 Millimeter
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Device Record Status
3f3ec62d-f483-432c-87c8-86db08d5d4dd
January 22, 2024
1
January 12, 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
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: 00810061911920 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8592594925
info@stepheninst.com
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