DEVICE: Clip-on Spielmann (B091121310)
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Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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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? |
|---|---|---|---|---|
| 46490 | Spectacle lens occluder |
A thin, plastic, flap-like device that is clipped onto the upper frame of a pair of existing spectacles (eyeware) to block vision through the spectacle lens. It is typically made of plastic and is available in preformed, leaf-shaped, disks, usually with a pair of clip on hinges on its top edge; it is subsequently applied to the exterior of the lens. The device is often used for children and is intended to be used prophylactically (e.g., to prevent amblyopia -- impairment of vision without apparent disease) and/or therapeutically [e.g., to treat squinting, double vision (diplopia), and problems due to absence of a natural lens (aphakia)]. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HPB | Clip, Lens, Trial, 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 |
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| No Device Sizes |
Device Record Status
3cb214fb-f7bc-4c85-b5bb-d8d23b85c1e3
July 13, 2023
1
July 05, 2023
July 13, 2023
1
July 05, 2023
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
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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