FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiMap™ System Interconnect Cable
DI: 00850064686098
·
Model: FG0005
·
Cortex, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OptiMap™ System Interconnect Cable
- Primary DI
- 00850064686098
- Version / Model
- FG0005
- Catalog Number
- OPTI-SIC
- Company Name
- Cortex, Inc.
- Labeler DUNS
- 119228234
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-24
- Public Version
- 2
- Public Version Date
- 2025-10-15
- Public Version Status
- Update
- Public Device Record Key
- c0d91ce1-049e-4c12-b058-97a93260a110
Device Description
OptiMap™ System Interconnect 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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46429 | Electrical-only medical device connection cable, reprocessed | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850064686098 | GS1 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius