FDA UDI
In Commercial Distribution
🇺🇸 United States
Insight Discovery Algometer
DI: 00890477000159
·
Model: 900-015-2
·
SRS Medical Systems, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Insight Discovery Algometer
- Primary DI
- 00890477000159
- Version / Model
- 900-015-2
- Company Name
- SRS Medical Systems, Inc.
- Labeler DUNS
- 796263598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-20
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 59f07787-b2b3-458c-8370-417624061e1b
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
- No
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44574 | Biofeedback system application software | An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
| 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 | 00890477000159 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063447 | 000 |