FDA UDI
In Commercial Distribution
🇺🇸 United States
Lead Adapter Cable
DI: 00873263008232
·
Model: MT-LA-04-00823
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lead Adapter Cable
- Primary DI
- 00873263008232
- Version / Model
- MT-LA-04-00823
- Catalog Number
- MT-LA-04
- Company Name
- FHC, INC.
- Labeler DUNS
- 108179458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 2
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 63fcd660-ba66-44c0-9e4e-367b0a46b8b5
Device Description
Lead Adapter Cable, 1x For use with Model B31040 lead test 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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GZL | ELECTRODE, DEPTH | Neurology | 882.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00873263008232 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183123 | 000 |