Identity
- Trade Name
- Burr FDA UDI
- Generic Name
- Corneal bur system, battery-powered FDA UDI
- Device Name
- DIAMOND BURR 3.3MM DIAMETER BALL FDA UDI
- Model / Reference
- K2-4923 FDA UDI
- Description
- DIAMOND BURR 3.3MM DIAMETER BALL FDA UDI
Identifiers
- Catalog Number
- K2-4923 FDA UDI
- Primary DI / UDI-DI
- 00841668113141 FDA UDI
- 510(k) Number
- K950520 FDA UDI
- FDA Product Code
- HOG FDA UDI
- GMDN Term
- Corneal bur system, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.3 Millimeter FDA UDI
Category: Corneal bur system, battery-powered
Burr by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K950520 also covers:
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
- Katena Products, Inc.
Sources (1)
- FDA UDI 705a2d23-5c61-4cb0-a1e5-50d571c88d24 37 fields · synced Jun 12, 2026