FDA UDI
In Commercial Distribution
🇺🇸 United States
Visitec®
DI: 30886158002377
·
Model: 581062
·
Beaver-Visitec International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Visitec®
- Primary DI
- 30886158002377
- Version / Model
- 581062
- Catalog Number
- 581062
- Company Name
- Beaver-Visitec International, Inc.
- Labeler DUNS
- 001406024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-27
- Public Version
- 1
- Public Version Date
- 2024-07-05
- Public Version Status
- New
- Public Device Record Key
- 82e2d988-d022-400b-8936-59ce73fee416
Device Description
CORNEAL LIGHT SHIELD 8MM L (20/SP)
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37940 | Retina illumination shield | A device typically made of a non-abrasive fluid-absorbing material (e.g., a sponge), intended to be placed on the surface of the cornea to shield the retina from excessive illumination during an ophthalmic procedure; it is not intended to protect the eye from exposure to harmful radiation. It is composed of material that resists the tearing or shredding of its fibres. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30886158002377 | GS1 |
Customer Contacts
- Phone
- +1(866)906-8080
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place.