DEVICE: NETCELL (05060165013807)
Device Identifier (DI) Information
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? |
|---|---|---|---|---|
| 13704 | Ophthalmic sponge |
A device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HOZ | Sponge, Ophthalmic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K130117 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
43de6c62-e0d8-4a43-ac37-3367cfcbf9f4
February 22, 2021
3
August 29, 2019
February 22, 2021
3
August 29, 2019
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
05060165018970
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined