FDA UDI
In Commercial Distribution
🇺🇸 United States
ri-vision with slit retinoscope XL/LED 3,5V, C han
DI: 04045396182783
·
Model: 3821-203
·
Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ri-vision with slit retinoscope XL/LED 3,5V, C han
- Primary DI
- 04045396182783
- Version / Model
- 3821-203
- Catalog Number
- 3821-203
- Company Name
- Rudolf Riester GmbH
- Labeler DUNS
- 537208717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-28
- Public Version
- 1
- Public Version Date
- 2021-02-05
- Public Version Status
- New
- Public Device Record Key
- a1f0d08f-7661-4ff3-8877-cdcf2cb4273c
Device Description
The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HKM | Retinoscope, Battery-Powered | Ophthalmic | 886.1780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45084 | Ophthalmic/otologic diagnostic set | A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396182783 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964338 | 000 |