FDA UDI
In Commercial Distribution
🇺🇸 United States
Wizard Wand
DI: 00850013958122
·
Model: WW-01
·
C F M TECHNOLOGIES INC
Product Codes
1
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wizard Wand
- Primary DI
- 00850013958122
- Version / Model
- WW-01
- Company Name
- C F M TECHNOLOGIES INC
- Labeler DUNS
- 040748944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-06
- Public Version
- 2
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- eda3964d-1fa3-4b89-ae08-01d990800a3b
Device Description
Wizard Wand Professional Eye Care Set. This kit contains a versatile set of components designed to facilitate effective examination of the eyes for foreign bodies and corneal abrasions and removal of foreign bodies from the conjunctiva.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HPN | Magnet, Permanent | Ophthalmic | 886.4445 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33737 | Corneal staining strip | A small absorbent strip, made of filter paper or similar material, which is impregnated with a small amount of a chemical (e.g., fluorescein sodium, lissamine green) intended to be applied to the cornea to function as a dye for ophthalmic examinations of the anterior segment of the eye. It is typically used to stain the cornea when fitting contact lenses, to disclose corneal injury (e.g., to enhance superficial abrasions for examination), in applanation tonometry, or evaluation of dry eye syndrome. This is a single-use device. | No | Active |
| 46718 | Eye magnet, non-powered | A non-electric hand-held instrument designed to generate a magnetic field intended to locate and remove metallic foreign bodies [typically those containing iron (Fe) or steel] from eye tissue; it may include a wire loop at one end for mechanical extraction. This is a reusable device. | No | Active |
| 45085 | ENT diagnostic set | A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and 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 | 00850013958122 | GS1 |
Customer Contacts
- Phone
- 6039243751
- [email protected]