FDA UDI
In Commercial Distribution
🇺🇸 United States
HIGH RESOLUTION LED LOUPE
DI: 00192896071681
·
Model: J-008.31.346
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HIGH RESOLUTION LED LOUPE
- Primary DI
- 00192896071681
- Version / Model
- J-008.31.346
- Catalog Number
- J-008.31.346
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-12
- Public Version
- 1
- Public Version Date
- 2018-10-15
- Public Version Status
- New
- Public Device Record Key
- fa38f0a2-2c66-4a5e-99ad-9cc4eb20e60d
Device Description
HIGH RESOLUTION LED LOUPE WITH I-VIEW & S-GUARD
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSP | LOUPE, DIAGNOSTIC/SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15652 | Loupe | A convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis, minor surgery, dermatology, or by persons with a strong eyesight impairment. The loupe is typically mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896071681 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 420 Millimeter Distance | ||
| Device Size Text, specify | 2.5x Magnification |