FDA UDI
In Commercial Distribution
🇺🇸 United States
Slit Lamp Adapter safety filters. Active safety filter for use in combination wi
DI: 08717872016580
·
Model: 7005.F11
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Slit Lamp Adapter safety filters. Active safety filter for use in combination wi
- Primary DI
- 08717872016580
- Version / Model
- 7005.F11
- Catalog Number
- 7005.F11
- Company Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Labeler DUNS
- 407522184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 82bd8ea8-ceda-48e1-986e-b88a9a9fc384
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17650 | Laser beam eye protector, staff | A protective device that is designed to be used by the surgical staff in an operating or treatment room where a laser is being used, in order to protect their eyes from injury during the laser surgery. It will typically be designed as goggles or special spectacles containing a filter glass that provides adequate visual transmission with high optical density (attenuation) for the specified laser wavelength which they will be using. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872016580 | GS1 |