FDA UDI
In Commercial Distribution
🇺🇸 United States
Clip-on Spielmann
DI: B091121310
·
Model: 1
·
Gulden Ophthalmics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Clip-on Spielmann
- Primary DI
- B091121310
- Version / Model
- 1
- Company Name
- Gulden Ophthalmics Inc.
- Labeler DUNS
- 002373249
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- 3cb214fb-f7bc-4c85-b5bb-d8d23b85c1e3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HPB | Clip, Lens, Trial, Ophthalmic | Ophthalmic | 886.1410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B091121310 | HIBCC |