FDA UDI
In Commercial Distribution
🇺🇸 United States
DIERS myoline
DI: 04260242060118
·
Model: professional
·
DIERS International GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DIERS myoline
- Primary DI
- 04260242060118
- Version / Model
- professional
- Company Name
- DIERS International GmbH
- Labeler DUNS
- 499189983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-02
- Public Version
- 1
- Public Version Date
- 2023-06-12
- Public Version Status
- New
- Public Device Record Key
- 90cd573a-6e5b-42de-85ab-b9c5a5ee3270
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | Physical Medicine | 890.1600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12692 | Myograph | A mains electricity (AC-powered) device designed for determining and recording the different phases of the intensity or velocity of a muscular contraction. It includes a sensor for detecting the displacement and/or force related to the muscle contraction and reproducing them in a graph (myogram). A myograph is used in the evaluation of muscles in several conditions, e.g., displacement under constant tension or force exerted under an isometric condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260242060118 | GS1 |