DEVICE: SOFT PLUG® Collagen Intracanalicular Plugs (10845819000295)

Device Identifier (DI) Information

SOFT PLUG® Collagen Intracanalicular Plugs
6503, B-6503
In Commercial Distribution

OASIS MEDICAL, INC.
10845819000295
GS1

6
194121018 *Terms of Use
SOFT PLUG® Collagen Intracanalicular Plug 0.3mm DIA x 2mm long
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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?
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
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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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

be088d0f-f7a6-45f8-a046-03120dfc4e9c
July 10, 2023
1
June 30, 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
20845819000292 10 10845819000295 In Commercial Distribution Carton
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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: 00845819000298 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
9093055400
customerservice@oasismedical.com
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