Identity
- Trade Name
- Visitec® FDA UDI
- Generic Name
- Corneal bur system, battery-powered FDA UDI
- Device Name
- EYE BANDAGE GUIBOR BUBBLE BANDAGE STERILE 10/BX FDA UDI
- Model / Reference
- 8590300 FDA UDI
- Description
- EYE BANDAGE GUIBOR BUBBLE BANDAGE STERILE 10/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30886158010129 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Corneal bur system, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Corneal bur system, battery-powered
Visitec® by Beaver-Visitec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Burr — Katena Products, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc · Class I
- ALGERBRUSH CORN RUST RING REM BURR 1.0MM — Katena Products, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beaver-Visitec International, Inc.
Sources (1)
- FDA UDI 19b67193-b03f-435a-ab89-99c0f78c5a5e 34 fields · synced Jun 8, 2026