OCULAR SHIELD
- Primary DI
- 00192896095342
- Brand
- OCULAR SHIELD
- Company
- SONTEC INSTRUMENTS, INC.
- Model
- 1100-408XSY
- Catalog number
- 1100-408XSY
- Device description
- OCULAR SHIELD BILATERAL WITH SUCTION CUP EXTRA SMALL SIZE TRANSPARENT YELLOW PLASTIC
- Published
- 2019-03-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| MOE | Collagen Corneal Shield |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
| MOE | Collagen Corneal Shield | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00192896095342 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00192896095342 | 00192896095342 | 192896095342 | 0192896095342 |
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. |
Sterilization Methods
| Method |
|---|
| Dry Heat Sterilization;Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 040729840
- 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
- true
- Sterilization required before use
- true
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