FDA UDI
In Commercial Distribution
🇺🇸 United States
RECHARGEABLE HANDLE & REFRACTION STAND ADAPTOR
DI: 05055272720007
·
Model: 1911-P-1244-500
·
KEELER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RECHARGEABLE HANDLE & REFRACTION STAND ADAPTOR
- Primary DI
- 05055272720007
- Version / Model
- 1911-P-1244-500
- Company Name
- KEELER LIMITED
- Labeler DUNS
- 210164398
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-27
- Public Version
- 1
- Public Version Date
- 2020-03-06
- Public Version Status
- New
- Public Device Record Key
- 43d80f52-15dc-4f87-9bc2-4e58294c0267
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 |
|---|---|---|---|---|
| HKL | Retinoscope, Ac-Powered | Ophthalmic | 886.1780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46784 | Retinoscope, line-powered | A mains electricity (AC-powered), hand-held, ophthalmic device 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 current power is run through a transformer for reduction to low-voltage. 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 | 05055272720007 | GS1 |