FDA UDI
In Commercial Distribution
🇺🇸 United States
BOVIE
DI: 00607151012052
·
Model: AB05
·
BOVIE MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BOVIE
- Primary DI
- 00607151012052
- Version / Model
- AB05
- Catalog Number
- AB05
- Company Name
- BOVIE MEDICAL CORPORATION
- Labeler DUNS
- 079940465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b5a9579e-80cb-4ffc-b2f9-3bdf288d6f38
Device Description
OPHTHALMIC BURR (1/2MM)
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 32812 | Corneal bur system, line-powered | An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, mains electricity (AC-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. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607151012059 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 00607151012052 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius