Cox® II, SS Ocular Laser Shield, left, small (non glare) w. handle, refurb.
Basic Information
- Brand Name
- Cox® II, SS Ocular Laser Shield, left, small (non glare) w. handle, refurb.
- Primary DI
- 10697660001583
- Version / Model
- 21-262HLRE
- Company Name
- Oculo-Plastik Inc
- Labeler DUNS
- 257382580
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-05
- Public Version
- 2
- Public Version Date
- 2022-03-25
- Public Version Status
- Update
- Public Device Record Key
- 150c99ce-917e-4e0f-bd11-584635b20a06
- Distribution End Date
- 2022-03-24
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.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | 886.4750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64271 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10697660001583 | GS1 |
Customer Contacts
- Phone
- 514-381-3292
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Thickness 1 Millimeter | ||
| Width | 21 | Millimeter | |
| Length | 24 | Millimeter |