DEVICE: MR PHACO (G412PH92140)
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Device Identifier (DI) Information
MR PHACO
PH9214
In Commercial Distribution
Crestpoint Management Limited
PH9214
In Commercial Distribution
Crestpoint Management Limited
Barraquer Eye Speculum, .035 Stainless Wire, 10mm Solid Blades Rounded, Temporal Approach, 15mm Blade Spread, 32mm Overall Length
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 35010 | Lacrimal dilator, reusable |
A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HNC | Specula, Ophthalmic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
3685d78a-ed9c-449f-bc5c-3f0c0cb84ddd
June 16, 2025
1
June 07, 2025
June 16, 2025
1
June 07, 2025
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined