Cox® II, SS Ocular Laser Shield, small (non glare), refurb.
- Primary DI
- 10697660001644
- Brand
- Cox® II, SS Ocular Laser Shield, small (non glare), refurb.
- Company
- Oculo-Plastik Inc
- Model
- 21-262RE
- Device description
- Cox® II ocular laser shields are intended to protect the eyes during IPL and laser procedures close to the eyes and on the face. They are inserted under the eyelids, on the ocular globes for the length of the procedure. They should not be left in place more than 60 minutes. The posterior polished surface and well-polished edges are intended to avoid corneal abrasions. The anterior surface is non-reflective treated to avoid reflection of the laser beam or IPL light source. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT OR RADIO FREQUENCY. After every case application and before sterilization, always verify visually and manually the condition of both surfaces and edges of the device. For the comfort and safety of the patient during insertion of the ocular shields an ophthalmic topical anaesthetic and ointment (non petroleum based for laser) is recommended. Users must choose a shield size appropriate to the globe. During periorbital surgery the shields should cover the entire globe.
- Published
- 2019-11-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10697660001644 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10697660001644 | 10697660001644 |
GMDN Terms
| Term | Definition |
|---|
| Radiation/mechanical corneal shield, reusable | A protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Length | 24 | Millimeter |
| Width | 21 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 257382580
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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