FDA UDI
In Commercial Distribution
🇺🇸 United States
Burr
DI: 00841668113141
·
Model: K2-4923
·
KATENA PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Burr
- Primary DI
- 00841668113141
- Version / Model
- K2-4923
- Catalog Number
- K2-4923
- Company Name
- KATENA PRODUCTS, INC.
- Labeler DUNS
- 085668598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-14
- Public Version
- 2
- Public Version Date
- 2022-12-15
- Public Version Status
- Update
- Public Device Record Key
- 705a2d23-5c61-4cb0-a1e5-50d571c88d24
Device Description
DIAMOND BURR 3.3MM DIAMETER BALL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HOG | Burr, corneal, battery-powered | Ophthalmic | 886.4070 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42443 | Corneal bur system, battery-powered | An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841668113141 | GS1 |
Customer Contacts
- Phone
- +1(973)989-1600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950520 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.3 | Millimeter |