FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoGlo®
DI: 00812594012679
·
Model: Aqua
·
Neotech Products LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeoGlo®
- Primary DI
- 00812594012679
- Version / Model
- Aqua
- Catalog Number
- N555AQ
- Company Name
- Neotech Products LLC
- Labeler DUNS
- 198013435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-16
- Public Version
- 7
- Public Version Date
- 2023-09-20
- Public Version Status
- Update
- Public Device Record Key
- 597f97ea-4f69-4ba1-ab61-0c71918e30f3
Device Description
The NeoGlo Transilluminator is a hand-held, battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HJN | Transilluminator, Battery-Powered | Ophthalmic | 886.1945 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36761 | Visible-light skin transilluminator | An electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812594012679 | GS1 |