FDA UDI
In Commercial Distribution
🇺🇸 United States
Bovie
DI: 10607151002258
·
Model: NLOT
·
BOVIE MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bovie
- Primary DI
- 10607151002258
- Version / Model
- NLOT
- Catalog Number
- NLOT
- Company Name
- BOVIE MEDICAL CORPORATION
- Labeler DUNS
- 079940465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 3
- Public Version Date
- 2018-05-25
- Public Version Status
- Update
- Public Device Record Key
- fabf5424-74d4-433f-8c0b-07229d7ee3f1
Device Description
SURCH-LITE ™ SURGICAL LIGHT 5'' (12.7cm)
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTF | Illuminator, Non-Remote | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38832 | Hand-held examination/treatment light | A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607151002258 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity