FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Alpine Biomed
DI: 00681490920674
·
Model: 9031C0521
·
Alpine Biomed ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alpine Biomed
- Primary DI
- 00681490920674
- Version / Model
- 9031C0521
- Company Name
- Alpine Biomed ApS
- Labeler DUNS
- 311231554
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 4
- Public Version Date
- 2020-04-29
- Public Version Status
- Update
- Public Device Record Key
- b769957b-ccb5-4fef-876a-1be84a0a449f
- Distribution End Date
- 2020-04-28
Device Description
8-channel EMG/EP Amplifier with 1.7 m cable
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 |
|---|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36728 | Electromyographic signal amplifier | An electronic device used with an electromyograph (EMG) to increase voltage, current, or power. This GMDN code may reflect old technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00681490920674 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944547 | 000 |