FDA UDI
In Commercial Distribution
🇺🇸 United States
AirRay® Electrode Connection Cable US
DI: 04260656590041
·
Model: Patient Cable 8 Channel
·
CorTec GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AirRay® Electrode Connection Cable US
- Primary DI
- 04260656590041
- Version / Model
- Patient Cable 8 Channel
- Catalog Number
- 4031.1055.02
- Company Name
- CorTec GmbH
- Labeler DUNS
- 341740910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-27
- Public Version
- 1
- Public Version Date
- 2022-05-05
- Public Version Status
- New
- Public Device Record Key
- 86d76ea2-02b3-446a-adcc-0a90b7f86b33
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35749 | Analytical scalp lead | A wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260656590041 | GS1 |
Customer Contacts
- Phone
- +4976170888100
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special Storage Condition, Specify: To be stored and used within typical hospital/office room ambient temperature (20°C±15°C/68°F±27°F) and non-condensing humidity conditions.