FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sierra Wave
DI: 00840067100523
·
Model: 199219-200
·
CADWELL INDUSTRIES, INC.
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sierra Wave
- Primary DI
- 00840067100523
- Version / Model
- 199219-200
- Company Name
- CADWELL INDUSTRIES, INC.
- Labeler DUNS
- 098554157
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 4
- Public Version Date
- 2024-01-09
- Public Version Status
- Update
- Public Device Record Key
- 85fc1155-6570-4a3d-98cd-e0619fda7bc5
- Distribution End Date
- 2024-01-01
Device Description
Acoustic Shielded Headphones
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| OLV | Standard polysomnograph with electroencephalograph | Neurology | 882.1400 | 2 |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | Neurology | 882.1870 | 2 |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE | Neurology | 882.1900 | 2 |
| OLT | Non-normalizing quantitative electroencephalograph software | Neurology | 882.1400 | 2 |
| IKN | Electromyograph, diagnostic | Physical Medicine | 890.1375 | 2 |
| GWQ | Full-montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| GWE | Stimulator, photic, evoked response | Neurology | 882.1890 | 2 |
| JXE | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT | Neurology | 882.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11474 | Electromyograph | An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840067100523 | GS1 |
Customer Contacts
- Phone
- +1(509)735-6481
- [email protected]