FDA UDI
In Commercial Distribution
🇺🇸 United States
ATLAS MICROMED JB INTERFACE
DI: 00850011306246
·
Model: ATLAS MICROMED JB INTERFACE
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ATLAS MICROMED JB INTERFACE
- Primary DI
- 00850011306246
- Version / Model
- ATLAS MICROMED JB INTERFACE
- Catalog Number
- 31-0601-0088
- Company Name
- NEURALYNX, INC.
- Labeler DUNS
- 933200842
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-07
- Public Version
- 3
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- 6f7f3fce-5c62-4918-856c-6e529e736367
Device Description
The ATLAS MICROMED JB INTERFACE is a buffered interface between Micromed Jackbox and ATLAS. The ATLAS MICROMED JB INTERFACE uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GWL | Amplifier, Physiological Signal | Neurology | 882.1835 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36740 | Electroencephalographic signal amplifier | An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011306246 | GS1 |
Customer Contacts
- Phone
- 4065854542
- [email protected]