FDA UDI
In Commercial Distribution
🇺🇸 United States
ri-scope® retinoscope head slit XL 3.5 V
DI: 04045396010819
·
Model: 10544
·
Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ri-scope® retinoscope head slit XL 3.5 V
- Primary DI
- 04045396010819
- Version / Model
- 10544
- Catalog Number
- 10544
- 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
- efbffb87-ba3b-476c-9b49-e78cf2504fac
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 |
|---|---|---|---|---|
| 32712 | Retinoscope, battery-powered | A battery-powered, hand-held, ophthalmic instrument that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The batteries may be of the rechargeable type, and are housed within the handle of the instrument. Also known as a skiascope and the method as sciascopy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396010819 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964338 | 000 |