FDA UDI
In Commercial Distribution
🇺🇸 United States
Daymark Headlight System
DI: 00851610007367
·
Model: P003060
·
LONG ISLAND TECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Daymark Headlight System
- Primary DI
- 00851610007367
- Version / Model
- P003060
- Company Name
- LONG ISLAND TECH
- Labeler DUNS
- 030256600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-07
- Public Version
- 1
- Public Version Date
- 2020-08-17
- Public Version Status
- New
- Public Device Record Key
- 057f5b4c-0026-4371-8933-3eeb03b534fc
Device Description
Light, Surgical, Accessory
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | 880.6350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46807 | Head-worn lamp | An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851610007367 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 60 – 80 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 86 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit